Methods and apparatus for fastening and clamping tissue

ABSTRACT

Methods and apparatus are provided for fastening or clamping tissue to tissue or non-tissue layers and for occluding tubular body structures. Tissue fasteners having separate proximal and distal implants, each with self-expanding, radially extending legs are connected together on opposite sides of tissue and non-tissue layers. The legs of the proximal and distal implants are interdigitated in the absence of such layers.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application is a continuation-in-part of pending prior U.S.patent application Ser. No. 14/639,814, filed Mar. 5, 2015 by AmselMedical Corporation and Arnold Miller et al. for METHOD AND APPARATUSFOR OCCLUDING A BLOOD VESSEL AND/OR FOR OCCLUDING OTHER TUBULARSTRUCTURES AND/OR FOR CLOSING OPENINGS IN STRUCTURES AND/OR FOR SECURINGAT LEAST TWO OBJECTS TOGETHER, which patent claims priority to priorapplications as set forth in the accompanying Application Data Sheetfiled herewith, all of which are hereby incorporated by reference, intheir entireties.

FIELD OF THE INVENTION

This invention relates to surgical methods and apparatus in general, andmore particularly to surgical methods and apparatus for fastening orclamping tissue layers together as well as for attaching non-tissuedevices or prostheses to tissue and to occlude tubular body structures.

BACKGROUND OF THE INVENTION

Numerous techniques and devices have been employed by surgeons andclinicians to attach tissue to tissue, to occlude tubular bodystructures, to attach non-tissue prostheses and devices to tissue, toprevent excess bleeding after tissue resection and the like. A partiallist would include sutures, staples, ligating clips, adhesives, clamps,cauterization, among others. The present inventions provide improvedmethods and devices for performing those and other like functions.

SUMMARY OF THE INVENTION

The present invention provides a new and improved approaches forfastening tissue to tissue, tissue to non-tissue, for clamping resectedtissue and for occluding blood vessels and other tubular bodystructures.

In one aspect, the present invention comprises the provision and use ofa novel tissue fastener (sometimes referred to as an “fastener”) thatcan be used in numerous surgical environments to attach tissue to tissueor to non-tissue prostheses. Fastener may be deployed using aminimally-invasive approach (i.e., either percutaneously orendoluminally), with visualization being provided by ultrasound and/orother visualization apparatus (e.g., CT, MRI, X-ray etc.) or may be usedunder direct visualization (e.g., during “open” surgery) or underindirect visualization (e.g., during laparoscopic surgery wherevisualization is provided through the use of a scope, or duringpercutaneous surgery where visualization is provided through the use ofimaging apparatus such as an ultrasound imager, an X-ray imager, etc.).

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and features of the invention will be appreciated more fullyfrom the following description of the illustrative embodiments, withreference to the accompanying drawings in which:

FIGS. 1-7 are diagrammatic representations of fasteners of theinvention;

FIGS. 8-24 illustrate an embodiment of the fastener and installationapparatus which may be used to deploy the two-part fastener;

FIGS. 25-45 illustrate the sequential steps in deploying the embodimentof FIGS. 8-24;

FIGS. 46-49 are schematic views showing a two-part fastener formed inaccordance with the present invention;

FIGS. 50-53 are schematic views showing still another two-part fastenerformed in accordance with the present invention;

FIGS. 54-57 are schematic views showing yet another two-part fastenerformed in accordance with the present invention;

FIGS. 58-61 are schematic views showing another two-part occluder formedin accordance with the present invention;

FIGS. 62-70 are schematic views showing an installation apparatus fordeploying the two-part occluder shown in FIGS. 58-61;

FIGS. 71-77 are schematic views showing another installation apparatusfor deploying the two-part occluder shown in FIGS. 58-61;

FIGS. 78-80 are schematic views showing another two-part occluder formedin accordance with the present invention;

FIGS. 81-83 are schematic views showing means for securing the two-partoccluder shown in FIGS. 78-80 to an installation apparatus;

FIG. 84 is a schematic view showing another two-part occluder formed inaccordance with the present invention;

FIGS. 85-90 are schematic views showing a placement device forfacilitating proper placement of an occluder so as to occlude a bloodvessel (or other hollow tubular body);

FIG. 91 is a schematic view showing a tool for lifting a blood vessel(or other hollow tubular body) away from an underlying anatomicalstructure so as to facilitate proper placement of an occluder;

FIGS. 92-94 are schematic views showing use of an fastener for closingoff an organ;

FIGS. 95 and 96 are schematic views showing the two-part fastener of thepresent invention being used to attach hernia mesh to tissue;

FIGS. 97-117 are schematic views showing how the distal and proximallegs of the two-part fastener may be aligned with one another, orinterdigitated between one another, when the two-part fastener isdeployed;

FIGS. 118-120 are schematic views showing additional ways in which theinterdigitation of legs may be used to occlude a structure;

FIGS. 121-124 are schematic views showing a single use delivery devicefor delivering an fastener;

FIGS. 125-128 are schematic views showing how a reusable handle may beused to deploy a plurality of fasteners;

FIGS. 129-171 are schematic views showing a multiple fastener deliverydevice which may be used to deploy a plurality of fasteners;

FIG. 172 is a schematic view showing a multiple fastener delivery devicewhere a plurality of fasteners are disposed serially within the deliverydevice;

FIGS. 173-175 are schematic views showing a two-part fastener havingasymmetric legs;

FIGS. 176-203 are schematic views showing various constructions forseparating the tissue to be occluded from the surrounding tissue, and/orfor protecting the surrounding tissue from damage during delivery of thefastener;

FIGS. 204-214 are schematic views showing another novel fastener formedin accordance with the present invention;

FIGS. 215 and 216 are schematic views showing how a substance may beintroduced into a vessel between two fasteners or upstream of a singlefastener;

FIGS. 217-232 are schematic views showing how the fastener may becombined with electrocautery; and

FIGS. 233-236 are schematic views showing a handle for deploying afastener.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

The present invention also provides new and improved surgical methodsand apparatus for occluding other tubular structures and/or for closingopenings in structures and/or for securing at least two objectstogether.

And the present invention provides new and improved surgical methods andapparatus for fastening mechanical structures to tissues or bloodvessels, for example, for drug delivery.

More particularly, the present invention comprises the provision and useof a novel fastener which is used to occlude a vein (e.g., the proximalsaphenous vein, the small saphenous vein, tributaries, the perforatorveins, etc.) so as to restrict blood flow through the vein and therebytreat varicose veins below the point of occlusion. Significantly, thenovel fastener is configured to be deployed using a minimally-invasiveapproach (i.e., either percutaneously or endoluminally), withvisualization being provided by ultrasound and/or other visualizationapparatus (e.g., CT, MRI, X-ray etc.). As a result, the novel treatmentcan be provided in a doctor's office, with minimal local anesthetic, andeffectively no post-operative care.

FIGS. 1-4 show, diagrammatically, a form of fastener 30 that maycomprise a transluminal section 85, a far side lateral projection 90 anda near side lateral projection 95, with the far side lateral projection90 and the near side lateral projection 95 being held in opposition toone another so as to close down a lumen of a blood vessel or attachlayers of tissue or non-tissue together. Such an arrangement may beprovided by many different types of structures, e.g., such as the“double T-bar” structure shown in FIGS. 5-7 where the transluminalsection 85 of the fastener 30 is formed out of an elastic material whichdraws the two opposing T-bars 90, 95 of the fastener together so as toprovide clamping or vessel occlusion. By way of further example but notlimitation, far side lateral projection 90 and near side lateralprojection 95 may be connected together by a loop of suture, with theloop of suture being lockable in a reduced size configuration with asliding locking knot.

Furthermore, multiple fasteners 30 may be used on tissue or to occlude ablood vessel more completely, or to occlude a blood vessel in multipleregions, or to attach a material (e.g., a drug or cellular deliveryelement) in multiple places to tissue or to a blood vessel. Thefasteners may be coated with a drug-eluting compound, or the fastenersmay be electrically charged to enhance or prevent clotting or to delivera desired compound or agent to the blood vessel, etc. If desired, thelocation of the occluding or attachment element may be preciselycontrolled to deliver the desired compound or agent at a specificanatomical location.

Drug/Cellular Delivery Applications

The fastener 30 may be modified so as to allow drug/cellular delivery atfixed points within or adjacent to the vasculature or other hollowbodily structure. In this form the device may be provided with adrug/cellular delivery body 105 attached thereto, is advanced across ablood vessel 110 or attached to tissue

Two-Part Fastener

Looking next at FIG. 8, there is shown a two-part fastener 200 formed inaccordance with the present invention. Two-part fastener 200 generallycomprises a distal implant 205 and a proximal implant 210.

Distal implant 205 is shown in further detail in FIGS. 9-12. Distalimplant 205 comprises a distal implant body 215 and a distal implantlocking tube 220. Distal implant body 215 comprises a tube 225 having adistal end 226, a proximal end 227, and a lumen 230 extendingtherebetween. Tube 225 is slit intermediate its length so as to define aplurality of legs 235. A set of inwardly-projecting tangs 240 are formedin tube 225 between legs 235 and proximal end 227. A set of windows 245are formed in tube 225 between inwardly-projecting tangs 240 andproximal end 227. Distal implant body 215 is preferably formed out of anelastic material (e.g., a shape memory material having superelasticproperties such as Nitinol or superelastic polymers, includingsuperelastic plastics) and constructed so that its legs 235 normallyproject laterally away from the longitudinal axis of tube 225 (e.g., inthe manner shown in FIGS. 9 and 10, however, due to the elastic natureof the material used to form distal implant body 215, legs 235 can beconstrained inwardly (e.g., within the lumen of a delivery needle, aswill hereinafter be discussed) so that distal implant body 215 canassume a substantially linear disposition. See, for example, FIG. 12,which shows legs 235 moved inwardly relative to the position shown inFIGS. 9 and 10. However, when any such constraint is removed, theelastic nature of the material used to form distal implant body 215causes legs 235 to return to the position shown in FIGS. 9 and 10.

Distal implant locking tube 220 (FIG. 11) comprises a generally tubularstructure having a distal end 250, a proximal end 260 and a lumen 262extending therebetween. A set of windows 265 are formed in the distalimplant locking tube 220, with windows 265 being disposed distal toproximal end 260.

Distal implant locking tube 220 is disposed within lumen 230 of distalimplant body 215. When distal implant 205 is in its aforementionedsubstantially linear condition (i.e., with legs 235 restrained in anin-line condition), distal implant locking tube 220 terminates wellshort of tangs 240 of distal implant body 215, so that the proximal end227 of distal implant body 215 can move longitudinally relative todistal end 226 of distal implant body 215. However, when the proximalend 227 of distal implant body 215 is moved distally a sufficientdistance to allow full radial expansion of legs 235 (see FIG. 8),locking tangs 240 of distal implant body 215 will be received withinwindows 265 of distal implant locking tube 220, whereby to lock distalimplant 205 in its radially-expanded condition (i.e., with legs 235projecting laterally away from the longitudinal axis of tube 225, e.g.,in the manner shown in FIGS. 9 and 10). Spot welds applied via openings270 formed in the distal end 226 of distal implant body 215 serve tolock distal implant locking tube 220 to distal implant body 215, wherebyto form a singular structure (see FIGS. 9 and 12).

Looking next at FIGS. 13 and 14, proximal implant 210 comprises a tube275 having a distal end 280, a proximal end 285, and a lumen 290extending therebetween. Tube 275 is slit at its distal end so as todefine a plurality of legs 295. A set of inwardly-projecting tangs 300are formed in tube 275 between legs 295 and proximal end 285. Proximalimplant 210 is preferably formed out of an elastic material (e.g., ashape memory material having superelastic properties such as Nitinol)and constructed so that its legs 295 normally project laterally awayfrom the longitudinal axis of tube 275 (e.g., in the manner shown inFIG. 13), however, legs 295 can be constrained inwardly (e.g., withinthe lumen of a delivery tube, as will hereinafter be discussed) so thatproximal implant 210 can assume a substantially linear disposition. See,for example, FIG. 14, which shows legs 295 moved inwardly relative tothe position shown in FIG. 13. However, when any such constraint isremoved, the elastic nature of the material used to form proximalimplant 210 causes legs 295 to return to the position shown in FIG. 13.

As will hereinafter be discussed, distal implant 205 and proximalimplant 210 are configured and sized so that tube 225 of distal implantbody 215 can be received in lumen 290 of proximal implant 210, with theexpanded legs 235 of distal implant 205 opposing the expanded legs 295of proximal implant 210 (see, for example, FIG. 45), whereby to impose aclamping action on the side wall of a blood vessel (e.g., vein) disposedtherebetween and thereby occlude the blood vessel, as will hereinafterbe discussed in further detail (or, as an alternative, the opposingexpanded legs of the proximal and distal implants could interdigitate toimpose the clamping action). Furthermore, distal implant 205 andproximal implant 210 are configured and sized so that they may be lockedin this position, inasmuch as inwardly-projecting tangs 300 of proximalimplant 210 will project into windows 245 of distal implant 205.

Two-part fastener 200 is intended to be deployed using associatedinstallation apparatus. This associated installation apparatuspreferably comprises a hollow needle 305 (FIG. 15) for penetratingtissue, a distal implant delivery tube 310 (FIG. 16) for deliveringdistal implant 205 through hollow needle 305 to the far side of theblood vessel which is to be occluded, a composite guidewire 315 (FIGS.17-22) for supplying support to various components during delivery anddeployment, a push rod 320 (FIG. 23) for delivering various componentsover composite guidewire 315, and a proximal implant delivery tube 330(FIG. 24) for delivering proximal implant 210 for mating with distalimplant 205, as will hereinafter be discussed.

Hollow needle 305 (FIG. 15) comprises a distal end 335, a proximal end340 and a lumen 345 extending therebetween. Distal end 335 terminates ina sharp point 350. In one preferred form of the invention, hollow needle305 comprises a side port 355 which communicates with lumen 345.

Distal implant delivery tube 310 (FIG. 16) comprises a distal end 360, aproximal end 365 and a lumen 370 extending therebetween.

Composite guidewire 315 (FIGS. 17-22) comprises a guidewire rod 370 anda guidewire sheath 380. Guidewire rod 370 comprises a distal end 385 anda proximal end 390. Distal end 385 terminates in an enlargement 395.Guidewire sheath 380 comprises a distal end 400, a proximal end 405 anda lumen 410 extending therebetween. The distal end 400 of guidewiresheath 380 comprises at least one, and preferably a plurality of,proximally-extending slits 415. Proximally-extending slits 415 open onthe distal end of guidewire sheath 380 and allow the distal end ofguidewire sheath 380 to radially expand somewhat. As will hereinafter bediscussed, guidewire rod 370 and guidewire sheath 380 are configured andsized so that guidewire rod 370 can be received in lumen 410 ofguidewire sheath 380. Furthermore, when guidewire rod 370 is forcedproximally relative to guidewire sheath 380, the proximally-extendingslits 415 in guidewire sheath 380 allow the distal end of the guidewiresheath 380 to expand somewhat so as to receive at least some of theenlargement 395 formed on the distal end of guidewire rod 370. As thisoccurs, the distal end of guidewire sheath 380 will expand radially.

Push rod 320 (FIG. 23) comprises a distal end 420, a proximal end 425and a lumen 430 extending therebetween.

Proximal implant delivery tube 330 (FIG. 24) comprises a distal end 435,a proximal end 440 and a lumen 445 extending therebetween.

Two-part fastener 200 and its associated installation apparatus arepreferably used as follows.

First, hollow needle 305 (carrying distal implant delivery tube 310therein, which in turn contains the composite guidewire 315 therein,upon which is mounted distal implant 205) is passed through the skin ofthe patient, through intervening tissue, and across the blood vessel(e.g., vein 450) which is to be occluded. See FIGS. 25-27. As this isdone, any blood flowing out side port 355 can be monitored—excessive orpulsatile blood flow can indicate that hollow needle has accidentallystruck an artery.

Next, hollow needle 305 is retracted, leaving distal implant deliverytube 310 extending across the blood vessel. See FIG. 25.

Then distal implant delivery tube 310 is retracted somewhat so as toexpose the distal ends of composite guidewire, or rod, 315 and distalimplant 205. See FIG. 26.

Next, composite guidewire 315, push rod 320 and distal implant 205 areall moved distally, so as to advance the distal ends of compositeguidewire 315 and the distal implant 205 out of the distal end of distalimplant delivery tube 310. As this occurs, legs 235 of distal implant205 are released from the constraint of distal implant delivery tube 310and expand radially. See FIGS. 27 and 28.

Then, with push rod 320 being held in place against the proximal end ofdistal implant 205, composite guidewire 315 is pulled proximally so asto bring the distal end of distal implant 205 toward the proximal end ofdistal implant 205, whereby to cause locking tangs 240 of distal implantbody 215 to enter windows 265 of distal implant locking tube 220,whereby to lock legs 235 in their radially-expanded condition (see FIG.29).

At this point, hollow needle 305, distal implant delivery tube 310 andpush rod 320 may be removed (FIG. 30), leaving distal implant 205mounted on composite guidewire 315, with the legs 235 fully deployed onthe far side of the blood vessel and the proximal end of distal implant205 extending into the interior of the blood vessel (FIG. 31).

Next, proximal implant delivery tube 330 (carrying proximal implant 210therein) is advanced down composite guidewire 315, until the distal endof proximal implant delivery tube 330 sits just proximal to the bloodvessel (FIGS. 32-35).

Then push rod 320 is used to advance the distal end of proximal implant210 out of the distal end of proximal implant delivery tube 330. As thisoccurs, legs 295 are released from the constraint of proximal implantdelivery tube 330 and open radially. See FIGS. 36-39.

Next, using push rod 320, proximal implant 210 is pushed distally asdistal implant 205 is pulled proximally using composite guidewire 315.More particularly, guidewire rod 370 is pulled proximally, which causesenlargement 395 on the distal end of guidewire rod 370 to expandguidewire sheath 380 to a size larger than lumen 262 in distal implantlocking tube 220, which causes guidewire sheath 380 to move proximally,which causes proximal movement of distal implant 205. As distal implant205 and proximal implant 210 move together, their legs 235, 295 compressthe blood vessel, thereby occluding the blood vessel. Distal implant 205and proximal implant 210 continue moving together untilinwardly-projecting tangs 300 of proximal implant 210 enter windows 245of distal implant 205, thereby locking the two members into positionrelative to one another. See FIG. 40.

At this point push rod 320 and proximal implant delivery tube 330 areremoved. See FIG. 41.

Next, composite guidewire 315 is removed. This is done by firstadvancing guidewire rod 370 distally (FIG. 42), which allows the distalend of guidewire sheath 380 to relax inwardly, thereby reducing itsouter diameter to a size smaller than lumen 262 in distal implantlocking tube 220. As a result, guidewire sheath 380 can then bewithdrawn proximally through the interior of two-part fastener 200. SeeFIG. 43. Then guidewire rod 370 can be withdrawn proximally through theinterior of two-part fastener 200. See FIG. 44.

The foregoing procedure leaves two-part fastener 200 locked in positionacross the blood vessel, with the opposing legs 235, 295 compressing theblood vessel, whereby to occlude the blood vessel.

FIGS. 46-49 illustrate an embodiment of a two-part fastener 200Aembodying principles of the invention. Two-part fastener 200 generallycomprises a distal implant 205A and a proximal implant 210A. Distalimplant 205A is shown in further detail in FIG. 48. Distal implant 205Acomprises a tubular distal implant body 215A having a distal end 226A, aproximal end 227A, and a lumen 230A. The distal end of the body 215A isslit to define a plurality of legs 235A that can extend generallyradially, as shown when the implant is released from its delivery tube.A set of windows 245A are formed in the tubular body. Distal implantbody 215A is preferably formed out of an elastic material (e.g., a shapememory material having superelastic properties such as Nitinol orsuperelastic polymers, including superelastic plastics) and constructedso that its legs 235 normally project radially outwardly as shown inFIGS. 47 and 48), however, due to the elastic nature of the materialused to form distal implant body 215A, legs 235A can be constrainedinwardly to a tubular shape containable within the lumen of a deliveryneedle. When any such constraint is removed, the elastic nature of thematerial causes legs 235A to return to their relaxed, expanded position.

FIGS. 46, 47 and 49 show proximal implant 210A comprises a tube 225Ahaving a distal end 280A, a proximal end 285A, and a lumen 290A. Theinner diameter of the lumen 290A of the tube is greater than the outerdiameter of the tubular body 215A of the distal implant so that it canreceive the proximal end of the distal body as shown in FIG. 47. Thedistal implant also is formed from a superelastic material and is slitat its distal end to define a plurality of legs 295A that will expand toa relaxed, radially extended shape when released from a delivery tube inthe same manner as the distal implant. A set of inwardly projectingtangs 300A are formed in tube 275A and are arranged to be received inthe windows 245A of the tubular body of the distal implant when theimplants are brought together, thus locking the implants together, asshown in FIG. 47. Tissue or non-tissue (or both) disposed between thelegs of the proximal and distal legs will be clamped with the tubularbody of the distal implant extending through an aperture in the tissueand/or non-tissue, transfixing them together (See FIG. 46). In thisembodiment, the implants may be formed to have relatively short tubularportions to define a low-profile configuration in which the height ofthe tubular body of the implant is no greater than about the maximumdiameter of its expanded legs.

Two-part fastener 200 may be deployed using associated installationapparatus that may comprise a hollow needle 305 (FIG. 15) forpenetrating tissue, a retention guidewire 315 (FIGS. 17-22) fortemporarily maintaining the position of the distal implant, a push rod320 (FIG. 23) for controlling the position of the proximal implant

Hollow needle 305 (FIG. 15) comprises a distal end 335, a proximal end340 and a lumen 345 extending therebetween. Distal end 335 terminates ina sharp point 350. Hollow needle 305 may have a side port 355 whichcommunicates with lumen 345.

The retention wire may be in the form of a composite guidewire 315(FIGS. 17-22) that includes an elongated guidewire rod 370 and aguidewire sheath 380 having a lumen that receives the rod. The distalend 385 of the guidewire rod 370 terminates in an enlargement 395. Thedistal end 400 of guidewire sheath 380 has proximally extending slits416 that allow the distal end of guidewire sheath 380 to expand radiallywhen the enlarged end of the rod 370 is drawn into the slit end of thesheath. The expanded end of the sheath can engage the deployed distalimplant to retain the distal implant in position while the proximalimplant is deployed.

In the deployment of the fastener, hollow needle 305, loaded with thedistal and proximal implants arranged in tandem, and with the retentionguidewire 315 extending through the implants is advanced to the tissuesite to be fastened or occluded with the needle passing through thelayers (tissue and/or non-tissue) to be fastened. As this is done, anyblood flowing out side port 355 can be monitored—excessive or pulsatileblood flow can indicate that hollow needle has accidentally struck anartery. With the distal tip of the needle located distally of the tissueand with the distal tip of the retention guidewire extended slightlybeyond the tip of the needle and in its slightly expanded configuration,the pusher tube is maintained in its position to maintain the positionsof the implants and the delivery needle is withdrawn proximally torelease the distal implant from the needle and to enable the legs of thedistal implant to expand. The retention guidewire maintains the distalimplant in its position. Next, with the proximal implant retained withinthe delivery needle, the needle is withdrawn sufficiently to locate theproximal implant on the proximal side of the layers to be fastened.Then, with the pusher tube in engagement with the proximal end of theproximal implant, the needle is further withdrawn to release theproximal implant. Then, by manipulating the retention guidewire and thepusher tube the implants can be drawn together to lock the implantstogether and fastening the layers together between the legs of theimplants. The retention guidewire then can be configured to a removablestate and, together with the pusher, can be removed from the patient.

FIGS. 50-53 illustrate another two-part fastener 200B. Two-part fastener200B is generally similar to the aforementioned two-part fastener 200A,except that distal implant 205B utilizes a friction fit to lock distalimplant 205B to proximal implant 210B.

FIGS. 54-57 illustrate another two-part fastener 200C having a distalimplant 205C and a proximal implant 210C. Two-part fastener 200C isgenerally similar to the aforementioned two-part fastener 200, exceptthat distal implant 205C comprises a tube 225C which receives andsecures the proximal ends of legs 235C. Legs 235C are preferablyelongated elements (e.g., bent wires) formed out of a superelastic shapememory material so as to provide the legs 235C with the desired degreeof elasticity.

The composite guidewire 315 can be replaced by an alternative guidewirewhich includes a mechanism for releasably binding the alternativeguidewire to distal implant 205. By way of example but not limitation,such an alternative guidewire may include screw threads, and distalimplant 205 may include a screw recess, so that the alternativeguidewire can be selectively secured to, or released from, the distalimplant 205, i.e., by a screwing action.

Looking next at FIGS. 58-61, there is shown another two-part fastener200E formed in accordance with the present invention. Two-part fastener200E generally comprises a distal implant 205E and a proximal implant210E.

Distal implant 205E comprises a distal implant body 215E and a distalimplant locking tube 220E. Distal implant body 215E comprises a tube225E having a distal end 226E and an opposing proximal end. Preferablydistal implant 205E has a lumen 230E extending distally from itsproximal end. Lumen 230E may extend along the entire length of distalimplant body 215E or it may terminate short of the distal end of distalimplant body 215E. By way of example but not limitation, where two-partfastener 200E is to be set over a guidewire, lumen 230E extends alongthe entire length of distal implant body 215E. Tube 225E is slitintermediate its length so as to define a plurality of legs 235E. Distalimplant body 215E is preferably formed at least in part out of anelastic material (e.g., a shape memory material having superelasticproperties such as Nitinol or superelastic polymers, includingsuperelastic plastics) and is constructed so that its legs 235E normallyproject laterally away from the longitudinal axis of tube 225E (e.g., inthe manner shown in FIGS. 58-61), however, due to the elastic nature ofthe material used to form at least the legs 235E of distal implant body215E, legs 235E can be constrained inwardly (e.g., within the lumen of adelivery needle, as will hereinafter be discussed) so that distalimplant body 215E can assume a substantially linear disposition (inwhich case the distalmost tips of legs 235E converge to form theaforementioned proximal end of distal implant body 215E). However, whenany such constraint is removed (e.g., when distal implant body 215 is nolonger constrained within a delivery needle), the elastic nature of thematerial used to form at least the legs 235E of distal implant body 215Ecauses legs 235E to assume the position shown in FIGS. 58-61.

In one preferred form of the invention, and as seen in FIGS. 58-60, legs235E of distal implant 205E extend at an acute angle to the longitudinalaxis of distal implant 205E, such that legs 235E collectively define aconcave region 236E.

Distal implant locking tube 220E (FIGS. 58-61) comprises a generallytubular structure having a distal end 250E and a proximal end 260E.Preferably distal implant locking tube 220E has a lumen 262E extendingdistally from proximal end 260E. Lumen 262E may extend along the entirelength of distal implant locking tube 220E or it may terminate short ofthe distal end of distal implant locking tube 220E. By way of examplebut not limitation, where two-part fastener 200E is to be set over aguidewire, lumen 262E of distal implant locking tube 220E extends alongthe entire length of distal implant locking tube 220E. A set ofcircumferential grooves or recesses 265E are formed in distal implantlocking tube 220E, with grooves or recesses 265E being disposedintermediate distal end 250E and proximal end 260E. Distal implantlocking tube 220E also comprises a first half 266E of a mechanicalinterlock for releasably securing distal implant locking tube 220E (andhence distal implant 205E) to a distal implant delivery tube 310E (seebelow). Distal implant locking tube 220E is preferably formed out of abiocompatible material which is relatively inelastic along its length,whereby to minimize lengthwise stretching, although it may be somewhatflexible, whereby to allow it to be delivered over a curved path. By wayof example but not limitation, distal implant locking tube 220E may beformed out of a titanium alloy such as Ti 5 AL-4V.

Distal implant locking tube 220E is disposed within, and extendsproximally from, lumen 230E of distal implant body 215E. Distal implantlocking tube 220E is secured to distal implant body 215E in ways wellknown in the art (e.g., by spot welding, adhesives, mechanicalinterlocks, etc.), whereby to collectively form a singular structure(see FIGS. 58-61). Note that by forming distal implant body 215E out ofan elastic material, and by forming distal implant locking tube 220E outof a material which is relatively inelastic along its length, distalimplant body 215E is easily deformable (e.g., so that its legs 235E canbe constrained within a delivery needle) while distal implant lockingtube 220E is fixed in configuration (e.g., so that it can serve to holdproximal implant 210E to distal implant 205E, as will hereinafter bediscussed).

Still looking now at FIGS. 58-61, proximal implant 210E comprises a tube275E having a distal end, a proximal end 285E, and a lumen 290Eextending therebetween. Tube 275E is slit at its distal end so as todefine a plurality of legs 295E. A set of inwardly-projecting tangs 300Eare formed in tube 275E, between legs 295E and proximal end 285E, forengaging the aforementioned grooves or recesses 265E in distal implantlocking tube 220E, as will hereinafter be discussed (note that, ifdesired, the locations and configurations of grooves or recesses 265Eand tangs 300E can be reversed, i.e., outwardly-projecting tangs 300Ecan be provided on distal implant locking tube 220E and grooves orrecesses 265E can be provided on the inner side wall of tube 275E, orother means can be provided for connecting tube 275E of proximal implant210E to distal implant locking tube 220E of distal implant 205E).Proximal implant 210E is preferably formed at least in part out of anelastic material (e.g., a shape memory material having superelasticproperties such as Nitinol) and constructed so that its legs 295Enormally project laterally away from the longitudinal axis of tube 275E(e.g., in the manner shown in FIGS. 58-61), however, legs 295E can beconstrained inwardly (e.g., within the lumen of a delivery needle, aswill hereinafter be discussed) so that proximal implant 210E can assumea substantially linear disposition (with the distal ends of legs 295Ecollectively forming the distal end of proximal implant 210E). However,when any such constraint is removed, the elastic nature of the materialused to form at least the legs 295E of proximal implant 210E causes legs295E to return to the position shown in FIGS. 58-61.

In one preferred form of the invention, and as seen in FIGS. 58-061,legs 295E of proximal implant 210E extend at an obtuse angle to thelongitudinal axis of proximal implant 210E, such that legs 295Ecollectively define a concave region 301E.

Note that the concavity of concave region 236E of distal implant 205E isthe reverse of the concavity of concave region 301E of proximal implant210E (in other words, and as seen in FIGS. 58-61, the concavity ofconcave region 236E of distal implant 205E faces the concavity ofconcave region 301E of proximal implant 210E).

As will hereinafter be discussed, distal implant 205E and proximalimplant 210E are configured and sized so that distal implant lockingtube 220E of distal implant 205E can be received in lumen 290E ofproximal implant 210E, with the expanded legs 235E of distal implant205E opposing the expanded legs 295E of proximal implant 210E (see, forexample, FIGS. 60 and 61), whereby to impose a clamping action on theside walls of a blood vessel (e.g., vein) disposed therebetween andthereby occlude the blood vessel, as will hereinafter be discussed infurther detail (or, as an alternative, the opposing expanded legs of theproximal and distal implants may interdigitate so as to further enhancethe clamping action. Furthermore, distal implant 205E and proximalimplant 210E are configured and sized so that they may be locked in thisposition, inasmuch as inwardly-projecting tangs 300E of proximal implant210E will project into circumferential grooves or recesses 265E ofdistal implant locking tube 220E of distal implant 205E, whereby tosecure proximal implant 210E to distal implant 205E. Note that thepositions of circumferential grooves or recesses 265E of distal implantlocking tube 220E and inwardly-projecting tangs 300E of proximal implant210E are coordinated so that when inwardly-projecting tangs 300E ofproximal implant 210E are disposed in circumferential grooves orrecesses 265E of distal implant locking tube 220E, legs 235E of distalimplant 205E and legs 295E of proximal implant 210E are sufficientlyclose to ensure adequate clamping of a blood vessel (or other tubularstructure) disposed therebetween.

Two-part fastener 200E is intended to be deployed using associatedinstallation apparatus. In one preferred form of the invention, suchassociated installation apparatus preferably comprises a hollow needle305E (FIG. 66) for penetrating tissue, a distal implant delivery tube310E (FIG. 67) for delivering distal implant 205E through hollow needle305E to the far side of the blood vessel (or other tubular structure)which is to be occluded, and a proximal implant delivery tube 330E (FIG.67) for delivering proximal implant 210E for mating with distal implant205E, as will hereinafter be discussed.

If desired, the associated installation apparatus may be provided in theform of a laparoscopic device 331E as shown in FIGS. 62-70. Laparoscopicdevice 331E comprises a handle 332E, an outer sheath 333E, a knob 334E,a first trigger 336E, a second trigger 337E and a release lever 338E,with the functionality hereinafter described.

More particularly, hollow needle 305E (FIG. 66) comprises a distal end335E, a proximal end (not shown, but contained within laparoscopicdevice 331E) and a lumen 345E extending therebetween. Distal end 335E ofhollow needle 305E terminates in a sharp point 350E.

Distal implant delivery tube 310E (FIG. 67) comprises a distal end 360Eand a proximal end (not shown, but contained within laparoscopic device331E). Distal end 360E of distal implant delivery tube 310E alsocomprises a second half 361E of a mechanical interlock for releasablysecuring the distal end of distal implant delivery tube 310E to theproximal end of distal implant 205E, i.e., by the releasableinterconnection of the first half 266E of the mechanical interlock(carried by the proximal end of distal implant locking tube 220E) withthe second half 361E of the mechanical interlock (carried by the distalend of distal implant delivery tube 310E).

Proximal implant delivery tube 330E (FIG. 67) comprises a distal end435E, a proximal end (not shown, but contained within laparoscopicdevice 331E) and a lumen 445E extending therebetween.

Two-part fastener 200E and its associated installation apparatus (e.g.,laparoscopic device 331E) are preferably used as follows.

First, hollow needle 305E is passed to the occlusion site, preferablywhile needle 305E is contained within sheath 333E of laparoscopic device331E (FIG. 64. Then sheath 333E is retracted, e.g., by turning knob 334E(FIG. 65), and hollow needle 305E is passed across the blood vessel(e.g., a vein) which is to be occluded (or passed across another tubularstructure which is to be occluded, or passed through tissue or objectsto be secured to one another, such as a solid organ, or layers oftissue, etc.).

Next, hollow needle 305E is retracted proximally, back across the bloodvessel, e.g., via first trigger 336E (FIG. 66). This action allows legs235E of distal implant 205E to expand radially on the far side of theblood vessel. At this point, distal implant locking tube 220E extendsproximally through the blood vessel.

Then, with distal implant delivery tube 310E held in place via distalimplant delivery tube 310E and its interlock with distal implant lockingtube 220E (and hence distal implant 205), hollow needle 305E iswithdrawn further proximally (e.g., via first trigger 336E) untilproximal implant 210E is no longer constrained within hollow needle 305E(FIG. 67). As this occurs, legs 295E of proximal implant 210E arereleased from the constraint of hollow needle 305E and open radially.

Proximal implant delivery tube 330E is then advanced distally, e.g.,using second trigger 337E, until proximal implant 210E and distalimplant 205E come together (FIG. 68). As distal implant 205E andproximal implant 210E move together, their legs 235E, 295E compress theblood vessel therebetween, thereby occluding the blood vessel. Distalimplant 205E and proximal implant 210E continue moving together untilinwardly-projecting tangs 300E of proximal implant 210E entercircumferential grooves or recesses 245E of distal implant 205E, therebylocking the two members into position relative to one another.

At this point, proximal implant delivery tube 330E is withdrawn (FIG.69), distal implant delivery tube 310E is released from distal implant205E (i.e., by using lever 338E to unlock the second half 361E of themechanical interlock (carried by the distal end of distal implantdelivery tube 310E) from the first half 266E of the mechanical interlock(carried by the proximal end of distal implant locking tube 220E), andthen the installation device is withdrawn (FIG. 70).

The foregoing procedure leaves two-part fastener 200E locked in positionacross the blood vessel, with the opposing legs 235E, 295E compressingthe blood vessel therebetween, whereby to occlude the blood vessel.

In the preceding disclosure, two-part fastener 200E is discussed in thecontext of using the elasticity of its legs 235E, 295E to cause its legs235E, 295E to reconfigure from a diametrically-reduced configuration(e.g., when constrained within a delivery needle) to adiametrically-expanded configuration (e.g., when released from theconstraint of a delivery needle). However, it should also be appreciatedthat where legs 235E, 295E are formed out of a shape memory material(e.g., Nitinol), a temperature change may be used to reconfigure legs235E, 295E from a diametrically-reduced configuration to adiametrically-expanded configuration. By way of example but notlimitation, in this form of the invention, legs 235E, 295E may beconstructed so as to have a diametrically-reduced configuration whenmaintained at a temperature below body temperature, and legs 235E, 295Emay be constructed so as to have a diametrically-expanded configurationwhen maintained at body temperature. As a result, by cooling two-partfastener 200E to a temperature below body temperature, inserting thetwo-part fastener into the body, and then allowing the two-part fastenerto heat to body temperature, legs 235E, 295E can be caused toreconfigure from their diametrically-reduced configuration to adiametrically-expanded configuration.

FIGS. 71-77 show an alternative form of installation device. Moreparticularly, FIGS. 71-77 show another laparoscopic device 331E. Thelaparoscopic device 331E shown in FIGS. 71-77 is generally similar tothe laparoscopic device 331E shown in FIGS. 62-70, except that secondtrigger 337E is omitted, and lever 338E is used to both: (i) advanceproximal implant delivery tube 330E until proximal implant 210E anddistal implant 205E come together (FIG. 76), and (ii) release distalimplant 205E from distal implant locking tube 220E (FIG. 77) (i.e., byunlocking the second half 361E of the mechanical interlock (carried bythe distal end of distal implant delivery tube 310E) from the first half266E of the mechanical interlock (carried by the proximal end of distalimplant locking tube 220E)).

FIGS. 78-80 show another two-part fastener 200E also formed inaccordance with the present invention. The fastener 200E shown in FIGS.78-80 is substantially the same as the fastener 200E shown in FIGS.58-77, except that legs 235E of distal implant 205E, and legs 295E ofproximal implant 210E, have their concavity directed in the samedirection, so that legs 235E, 295E nest with one another rather thanconfront one another. In addition, as seen in FIGS. 78-80, tube 225E ofdistal implant 205E is partially received in lumen 290E of proximalimplant 210E.

FIGS. 81-83 show one preferred construction for releasably securingdistal implant 205E of the two-part fastener 200E of FIGS. 78-80 todistal implant delivery tube 310E. More particularly, in this form ofthe invention, and looking now at FIGS. 81-83, the first half 266E ofthe mechanical interlock (carried by the proximal end of distal implantlocking tube 220E) comprises a stepped configuration 433E, and thesecond half 361E of the mechanical interlock (carried by the distal endof distal implant delivery tube 360E) comprises another steppedconfiguration 434E, wherein stepped configuration 433E and steppedconfiguration 434E are inverses of one another so as to mate together.After the second half 361E of the mechanical interlock (carried by thedistal end of distal implant delivery tube 310E) has been secured to thefirst half 266E of the mechanical interlock (carried by the proximal endof distal implant locking tube 220E), the connection between distalimplant delivery tube 310E and distal implant 205E can be enhanced,e.g., by telescopically projecting a locking rod 436E out of a centrallumen 437E of distal implant delivery tube 310E and into lumen 262E ofimplant locking tube 220E. In this form of the invention, theinstallation device (e.g., laparoscopic device 331E of FIGS. 62-70, orlaparoscopic device 331E of FIGS. 71-77) include appropriate controlmeans (e.g., release lever 338E) for telescopically moving locking rod436E out of central lumen 437E of distal implant delivery tube 310E andinto lumen 262E of implant locking tube 220E. Alternatively, in anotherform of the invention, internal locking rod 436E may be replaced by anovertube (not shown) which telescopically projects over distal implantdelivery tube 310E and distal implant locking tube 220E of distalimplant 205E, whereby to enhance the connection between the members.

It should also be appreciated that other forms of mechanical interlocksmay be used for releasably securing distal implant 205E of the two-partfastener 200E of FIGS. 78-80 to distal implant delivery tube 310E. Byway of example but not limitation, a screw interlock may be used, e.g.,the first half 266E of the mechanical interlock (carried by the proximalend of distal implant locking tube 220E) may comprise a threaded bore,and the second half 361E of the mechanical interlock (carried by thedistal end of distal implant delivery tube 360E) may comprise a threadedpost, wherein the threaded post carried by the distal end of distalimplant delivery tube 360E may be received in the threaded bore ofdistal implant locking tube 220E. Alternatively, other configurations ofa screw interlock may be used, or other forms of mechanical interlocksmay be used.

In the constructions shown in FIGS. 58-80, a mechanical interlock (e.g.,a first half 266E carried by the proximal end of distal implant lockingtube 220E and a second half 361E carried by the distal end of distalimplant delivery tube 310E) is used to connect distal implant lockingtube 220E (and hence distal implant 205E) to distal implant deliverytube 310E. Alternatively, if desired, distal implant locking tube 220Ecan be formed integral with distal implant delivery tube 310E, with aweakened section disposed at their intersection, and the two membersseparated by a mechanical breaking action.

It will be appreciated that, in certain circumstances, it may bedesirable to increase the surface area of those portions of the fastenerwhich contact the tubular structure, in order to better distribute theload applied to the tissue. In this situation, it can be helpful toincrease the width of the legs (e.g., legs 235E and/or legs 295E oftwo-part fastener 205E, etc.), and/or to provide flexible material inthe zone between adjacent legs (e.g., in the manner of an umbrella) sothat the flexible material can also carry load (i.e., essentiallyincreasing the effective width of legs 235E and/or legs 295E). See, forexample, FIG. 84, which shows flexible material 438E extending betweenlegs 235E and legs 295E.

FIGS. 85-90 show a placement device 500 for the facilitating properplacement of the fastener (e.g., the two-part fastener 200E) so as toocclude a blood vessel (or other hollow tubular body). Placement device500 generally comprises a blood vessel locator needle 505, which is aneedle of relatively small diameter (e.g., 21 gauge or smaller), and aguiding component 510 (which may be manufactured from an inexpensivematerial such as plastic). Guiding component 510 includes a seat 515 forreceiving blood vessel locator needle 505, and an opening 520 forslidably accommodating the shaft of an installation device for settingthe fastener (e.g., laparoscopic device 331E of FIGS. 62-70, orlaparoscopic device 331E of FIGS. 71-77, etc.).

In use, blood vessel locator needle 505 is positioned in seat 515 ofguiding component 510, and then the blood vessel locator needle 505 isadvanced through the target blood vessel (e.g., under ultrasoundguidance). See FIG. 86. Proper placement of blood vessel locator needle505 is confirmed as blood begins to flow out the proximal end of bloodvessel locator needle 505. Next, the shaft of the installation devicefor setting the fastener (e.g., laparoscopic device 331E of FIGS. 62-70,or laparoscopic device 331E of FIGS. 71-77, etc.) is advanced throughopening 520 of guiding component 510. See FIG. 87. Advancement occursuntil a stop 525 on the shaft of the installation device engages theproximal end of guiding component 510. See FIG. 88. When stop 525 on theshaft of the installation device engages the proximal end of guidingcomponent 510, the distal end of the shaft of the installation devicewill have passed through the target blood vessel. See FIG. 89. At thispoint, blood vessel locator needle 505 is withdrawn (see FIG. 90) anddeployment of the fastener proceeds as previously discussed.

It will be appreciated that, in certain circumstances, the blood vessel(or other tubular structure) to be occluded may be positioned close toan underlying anatomical structure, e.g., an organ, a nerve, anothertubular structure, etc. In this situation, it may be helpful to lift theblood vessel (or other tubular structure) upward, away from theunderlying anatomical structure, so that the sharp distal tip of thedeployment needle does not engage the underlying anatomical structure,and so that the distal end of the fastener (e.g., distal implant 205E oftwo-part fastener 200E) does not engage the underlying anatomicalstructure, since any such engagement with the underlying anatomicalstructure could cause trauma to the underlying anatomical structure. Tothat end, and looking now at FIG. 91, clamping forceps 530 (or othertool having a bifurcated distal end) may be placed between the bloodvessel (or other tubular structure) and the underlying anatomicalstructure, and then pulled upwardly, away from the underlying anatomicalstructure, so as to separate the target blood vessel (or other tubularstructure or tissue) from the underlying anatomical structure. Thefastener (e.g., two-part fastener 200E) may then be safely passedthrough the target blood vessel (or other tubular structure), passingbetween the bifurcated distal end of the tool, and deployed aspreviously discussed.

Using the Fastener to Occlude Tubular Structures other than BloodVessels

It will be appreciated that the fastener of the present invention canalso be used to occlude tubular structures other than blood vessels. Byway of example but not limitation, the temporary fastener of the presentinvention can be used to occlude other structures within the body (e.g.,tubes such as fallopian tubes and/or vas deferens for temporary orpermanent sterilization, ducts such as bile ducts and cystic ducts forcholecystectomy, lymphatic vessels, including the thoracic duct, fistulatracts, etc.).

Using the Fastener to Close Openings in Structures and/or for Securingat Least Two Objects Together

In the foregoing disclosure, the fastener is discussed in the context ofoccluding a tubular structure (e.g., a blood vessel, fallopian tubes,lymphatic vessels, etc.) by clamping together opposing side walls of thetubular structure in order to occlude the tubular structure. In such anapplication, the fastener effectively secures one side wall of thetubular structure to the opposing side wall of the tubular structure.However, it should also be appreciated that the fastener of the presentinvention may be used to close openings in structures and/or to securetwo or more objects together for other applications.

By way of example but not limitation, the fastener of the presentinvention may be used to secure two or more portions of tissue togetherso as to close an incision.

By way of further example but not limitation, the fastener of thepresent invention may be used in a “stomach stapling” procedure to bringtogether opposing side walls of the stomach in order to reduce the sizeof the stomach.

Furthermore, the fastener of the present invention may be used in anorgan resection (e.g., a liver resection), so as to seal the peripheryof the resected organ.

By way of further example but not limitation, and looking now at FIGS.92-94, the fastener of the present invention can be used for selectivelyclamping or occluding regions of solid organs so as to selectively stopblood flow or blood loss in various regions through tissue compression.The fastener may be used in solid organ resection of the kidney or liveror other organs. Blood loss and secretion leakage (e.g., bile, urine,etc.) can be problematic in existing solid organ resection procedures.Average blood loss for a liver resection is 700-1200 ml. By clampingdesired regions of the solid organ with the fastener of the presentinvention, it is possible to significantly reduce the amount ofundesirable fluid loss (blood loss, secretion leakage, etc.). Thefastener of the present invention, can be used to apply pressureselectively to broad areas of the organ and, additionally, may also beused to close off selective tubular structures and vessels connectingthe organ with other regions of the body. In one embodiment and method,multiple discrete fastener elements may be individually, selectivelydeployed across regions of the organ. See, for example, FIG. 92, whichshows multiple, single, separate puncture placements of the fastener forclosing off a resected liver. Note that where multiple, single, separatepuncture placements of the fastener are used, different regions of thesolid organ may be compressed to different and controllable degrees.

In a novel embodiment of the present invention, the length of distalimplant locking tube 220E (of distal implant 205E) remaining in the bodycan be determined once clamping of the fastener has been effected, byproviding distal implant locking tube 220E and/or distal implantdelivery tube 310E with weakened (e.g., frangible) sections, and bybreaking off distal implant locking tube 220E from distal implantdelivery tube 310E at a region above proximal implant 210E. This breakcan be achieved by incorporating selective weakened regions into thedistal implant locking tube 220E and/or distal implant delivery tube310E, so that when a selective weakened region is subjected to twists,or torques, or bending, or pulling, or selective other strains orstresses or the like, distal implant locking tube 220E will separatefrom distal implant delivery tube 310E at a location proximal toproximal implant 210E. Because clamping is effected across the tissue,distal implant locking tube 220E connecting distal implant body 215 andproximal implant 210E will not move, while distal implant delivery tube310E will disconnect from distal implant locking tube 220E. Distalimplant locking tube 220E, which connects distal implant body 215E andproximal implant 210E, may be solid or flexible.

In other embodiments of the present invention, distal implant lockingtube 220E may be composed of multiple interlocking sections, andconstrained by an encasing sheath, or once deployed, by the surroundingtissue. Once clamping of the tissue is achieved, the sheath can beretracted beyond the proximal implant, exposing an interlocking regionbetween the distal implant locking tube 220E sections and then, with atwist, or appropriate unlocking mechanism, enable the fastener to bedisconnected from the distal implant delivery tube 310E.

This construction enables the clamping distance between distal implant205E and proximal implant 210E to be controllable, and allows forsignificant tissue thicknesses to be clamped.

In the embodiment shown in FIG. 93, the fasteners are delivered inconjunction with single or multiple compression bands 550, which may bepolymers, or other tissue material or metals or other commonly usedmaterials known in the art. The compression bands 550 may be rolled intothe delivery needle or sheath and unfurled prior to delivery of thefasteners. The compression bands 550 extend the pressure across abroader region of the organ or tissue which receives the fasteners ofthe present invention.

In other embodiments, the legs of the fastener may have a thin metallicor polymeric mesh or film that is flexible, yet connects between thefingers, to enable further distribution of pressure on a clamped tissue,vessel, organ or the like.

In the embodiment of FIG. 94, multiple fasteners can be delivered inparallel to an organ, tissue, tubular structure or the like. In thisform of the invention, an installation device 555, comprising a body 560having a plurality of deployment needles 565 extending therefrom, can beused for setting the multiple fasteners. Installation device 555 candeliver either single fasteners deployed one at a time, but in aspatially-constrained way, with a pre-defined spacing between thefasteners (determined by the predefined spacing between deploymentneedles 565), or can deliver a plurality of fasteners all at the sametime, with a single activation control. This construction can reduce theamount of time required for a procedure such as a resection, byproviding for simultaneous fastener deployments.

In other embodiments of the present invention, the fasteners can bedeployed across multiple tissues, or multiple folds of the same tissue,organ or tubular structure. In certain embodiments of the presentinvention, the distal implant locking tube 220E may be elastic, allowingfor some movement of the clamped tissue, while still maintaining adesired clamping force or pressure on the tissue.

The fasteners of the above invention may also be used for bariatricsurgery, or to reduce or plicate the stomach, or to create a gastrostomysleeve.

In another embodiment of the present invention, the unreleased distalimplant 205E can be used as the retractor, and retract the tissue awayfrom any organs or tissues or major blood vessel beneath, enablingsubsequent deployment of other fasteners to be placed in a manner thatmay enable reduction of the size of an organ, joining organs together,closing a tear in the bowel or the like. Once the other desiredfasteners have been deployed, the deployment of the first fastener(i.e., unification of the proximal implant 210E with the distal fastener205E) can be completed.

Use of the Invention Under Direct Visualization and/or IndirectVisualization

Significantly, the present invention may be practiced under directvisualization (e.g., during “open” surgery) or under indirectvisualization (e.g., during laparoscopic surgery where visualization isprovided through the use of a scope, or during percutaneous surgerywhere visualization is provided through the use of imaging apparatussuch as an ultrasound imager, an X-ray imager, etc.).

Enhanced Tissue, Organ, Duct and/or Vessel Clamping or Approximation

1. Advantages of Using Two-Part Fastener

The present invention relates to, among other things, a novel two-partfastener that clamps hollow tubes, vessels and/or at least two layers ofmaterials (i.e., biological materials or synthetic materials) together,and is an improvement over existing occlusion devices such as clamps orstaples, and may connect different or similar tissues together and/orconnect tissues to synthetic materials.

More particularly, the present invention relates to an apparatus andmethod for permanently, and controllably, bringing at least two surfacesinto at least partial contact or proximity with each other. The presentinvention can be used for occlusion of tubular structures such as veins,arteries, bile ducts, fallopian tubes, cystic ducts, etc. The presentinvention can also be used to bring, attach and/or connect at least twofolds (e.g., two sides of the stomach, or other parts of the legs, etc.)together so that they are connected.

The present invention can also be used to connect tissue with othermaterials, e.g., graft materials, hernia meshes, drug deliverymaterials, etc. The present invention is also intended to connect twostructures together with or without the need to protect the underlyingtissue layers from possible injury by the transfixing needle.

2. Drawbacks of Using Staples

The advantages of the present invention include, but are not limited to,secure clamping of vessels (or tissues) by transfixing the vessel (ortissue) so that the two-part fastener cannot be dislodged and slip offof the vessels (or tissues) with untoward consequences such as bleedingin blood vessels, and detachment of tissues, etc. Furthermore,compression of the vessel (or tissues) surrounding the puncture hole isaccomplished with distributed pressure on the vessel (or tissue) fromthe two-part fastener preventing any leakage of blood or fluids from theoccluded structure.

More particularly, two-part fastener 200 is disposed across the vesselwhich is to be occluded (or across the tissue(s) which are to be clampedtogether) such that distal implant 205 resides on one side of the vesseland proximal implant 210 resides on the other side of the vessel, withdistal implant locking tube 220 passing through the vessel andconnecting together distal implant 205 and proximal implant 210, wherebyto generate a clamping force therebetween. This distributed pressure(i.e., compression), around the puncture hole, helps to prevent fluids(e.g., blood or bile) from leaking out of the puncture hole (i.e., thehole in the vessel where distal implant locking tube 220 passes throughthe vessel) after the aforementioned distal implant 205 and proximalimplant 210 are brought together about the tissue to be clamped. Unlikea staple, which may produce bleeding where the legs of the staple passthrough the vessel and which can “slip off” of the vessel, distalimplant 205 and proximal implant 210 cannot “slip off” of the tissue.The distributed pressure around the puncture hole greatly reduces thepossibility of the tissue ripping.

Bleeding, “slipping off” of tissue and ripping through tissue are commonproblems associated with using staples, and with using other clips (suchas hemoclips) and clamps. Two-part fastener 200 of the present inventionis able to hermetically close a vessel experiencing a pressure of 0 mmHg up to, and above, 700 mm Hg (i.e., pressures at which theaforementioned issues associated with staples and prior-art clampsoccur).

The novel two-part fastener 200 of the present invention also eliminatesthe need for an additional support material when clamping delicatetissue.

For example, one prior art medical stapling device requires theprovision of additional support material when stapling fragile tissues.More particularly, this prior art medical stapling device uses anadditional advanced polymer felt material placed on the tissues andstapled together with the tissues.

3. Attaching Two Objects Together Using Two-Part Fastener 200

As discussed above, two-part fastener 200 may be used for occlusion oftubular structures such as, veins, arteries, bile ducts, cystic ducts,fallopian tube, etc.). However, it should also be appreciated thattwo-part fastener 200 may be used to attach a non-tissue element totissue (e.g., to attach hernia mesh to tissue, or a blood vesselstent-graft to the native vessel). Two-part fastener 200 may also beused to attach a first non-tissue element to a second non-tissue element(e.g., to attach a synthetic hernia mesh to the normal tissuessurrounding edges of the hernia site, or to another segment of herniamesh), e.g., for shaping or reconfiguring a non-tissue element.

It will be appreciated from the preceding disclosure that distal implantlocking tube 220 of two-part fastener 200 passes through the tubularstructure which is to be clamped, however, the entire area around distalimplant locking tube 220 is compressed/closed-off so as to prevent anybleeding or leakage of fluids from occurring at the site of theentry/exit point of distal implant locking tube 220 through the sidewalls of the tubular structure.

FIGS. 95 and 96 show two-part fastener 200 being used to clamp, forexample, hernia mesh to tissue.

4. Two-Part Fastener 200 with Interdigitated Fingers

In addition to the foregoing advantages (over prior art clamps andstaples) of using two-part fastener 200 to occlude a tubular structure,it should also be appreciated that the provision and use of a two-partfastener 200 having interdigitated legs (i.e., legs 235 of distalimplant 205 and legs 295 of proximal implant 210) allows a tubularstructure to be safely occluded in a way that avoids the problemsassociated with staples or clips (e.g., hemoclips, Ligaclips, etc.) (seeabove) and which allows the clamping force which is used to beadjustable.

In a preferred embodiment, the present invention generally comprises twocompression elements, a proximal implant 210 for compressing the nearwall of the vessel, and a distal implant 205 for compressing the farwall of the vessel. Proximal implant 210 and/or distal implant 205 maybe made of a shape memory metal (e.g., Nitinol), other biocompatiblemetals and/or ceramics, and/or various polymers and biodegradablepolymers that assume their designated configuration when two-partfastener 200 is used to occlude a vessel. Proximal implant 210 comprisesa plurality of legs 295 for applying clamping pressure to the proximalside of a vessel which is to be occluded and distal implant 205comprises a plurality of legs 235 for applying clamping pressure to thedistal side of a vessel which is to be occluded.

FIGS. 97 and 98 show two-part fastener 200 being used to occlude a bloodvessel (or clamp tissue). In one preferred embodiment of the presentinvention, distal implant 205 is pre-attached to (or formed integralwith) distal implant locking tube 220 (also sometimes referred to hereinas the implant locking rod, which also may be made of an organic,ceramic, or biodegradable polymer). In one embodiment of the presentinvention, distal implant 205 is secured to distal implant locking tube220 through welding. By way of example but not limitation, distalimplant 205 may be welded to distal implant locking tube 220 using awelding material introduced at least in part into a welding hole 600formed in distal implant locking tube 220 (see FIG. 102). In anotherembodiment of the present invention, distal implant 205 is secured todistal implant locking tube 220 through a mechanical locking, latchingor threaded screw arrangement. In another embodiment of the presentinvention, distal implant 205 and distal implant locking tube 220 areformed out of one contiguous piece and material. Proximal implant 210 ispreferably locked to distal implant locking tube 220 by way ofinwardly-oriented flaps (i.e., inwardly-projecting tangs 300) which areformed in the body of proximal implant 210 and lock into correspondingopenings (i.e., windows 265) formed in distal implant locking tube 220.It should be appreciated that, if desired, flaps (i.e.,inwardly-projecting tangs 300) may be formed on distal implant lockingtube 220 as outwardly projecting tangs, with corresponding openings(i.e., windows 265) being formed in proximal implant 210 (i.e., toreceive the flaps formed on distal implant locking tube 220). There maybe one window 265, or 2 windows 265, or 3 or more windows 265. Windows265 may cover 1%-100% of the circumference of distal implant lockingtube 220, or 1%-95% of the circumference of distal implant locking tube220 if windows 265 are located on proximal implant 210.

Two-part fastener 200 is capable of generating an occlusion pressure(i.e., a clamping force between proximal implant 210 and distal implant205) which is sufficient to clamp a blood vessel with a pressure of atleast 100 mm Hg. In another embodiment of the present invention,two-part fastener 200 is capable of withstanding a pressure of up to 300mm Hg, and in a further embodiment of the present invention, two-partfastener 200 is capable of supporting a pressure of over 700 mm Hg. FIG.97 shows the interdigitation (i.e., circumferential offset) of legs 295of proximal implant 210 and legs 235 of distal implant 205.

5. Adjustable Clamping Force

In a further embodiment of the present invention, the amount of pressure(i.e., the amount of clamping force) that two-part fastener 200 appliesto the tissues, or across a blood vessel, can be variably controlled.

More particularly, FIG. 99 illustrates how the gap between legs 235 ofdistal implant 205 and legs 295 of proximal implant 210 can becontrolled, effectively controlling the amount of pressure applied tothe tissue being clamped, or the degree to which the aperture (i.e.,lumen) of the vessel being transfixed by two-part fastener 200 isoccluded.

FIG. 100 shows one embodiment of the present invention wherein distalimplant locking tube 220 comprises a controllable ratcheting mechanismfor selectively controlling the spacing between proximal implant 210 anddistal implant 205 of two-part fastener 200. In this form of theinvention, legs 235 of distal implant 205 and legs 295 of proximalimplant 210 are generally oriented primarily in a parallel orientationto each other, and the distal and proximal fingers are aligned so thatthey overlapping. FIG. 101 shows an external view of a ratchetingmechanism of the present invention which allows a variable dispositionof proximal implant 210 and distal implant 205 relative to one another.

In this form of the present invention, distal implant locking tube 220comprises a plurality of windows 265 (e.g., a plurality of circulargrooves) formed along its length. Proximal implant 210 comprises aplurality of inwardly-projecting tangs 300 formed at a point along itslength. As proximal implant 210 is advanced distally towards distalimplant 205, inwardly-projecting tangs 300 enter into windows 265,thereby locking proximal implant 210 to distal implant 205.Inwardly-projecting tangs 300 are configured so that proximal implant210 can only move in a single direction (i.e., distally) relative todistal implant 205. As proximal implant 210 is advanced distallyrelative to distal implant 205, inwardly-projecting tangs 300 can slideout of windows 265 and enter windows 265 located distally. If desired,windows 265 may comprise a chamfered distal edge to facilitate movementof inwardly-projecting tangs 300 out of windows 265 as proximal implant210 moves distally relative to distal implant 205.

See also FIG. 102, and note the “notch-to-notch distance” (i.e., thedistance between windows 265) which governs the ability to vary thedegree of compression established between legs 235 of distal implant 205and legs 295 of proximal implant 210.

The degree of overlap and/or alignment of legs 235 of distal implant 205and legs 295 of proximal implant 210 can be controllably adjusted inseveral ways. First, the locking mechanism (e.g., theinwardly-projecting tangs 300 of proximal implant 210 and windows 265 ofdistal implant 205) may be appropriately positioned relative to oneanother so as to set the orientation of proximal implant 210 relative todistal implant 205 prior to locking.

In one form of the present invention, and looking now at FIGS. 103-106,there is provided a mechanism for setting the rotational orientation ofproximal implant 210 relative to distal implant 205. FIG. 103 shows themechanism for alignment and orientation control of the proximal implant210 through an orientation alignment groove (or notch) 605 formed in theproximal end of proximal implant 210, and a corresponding orientationalignment post (or tab) 610 formed in proximal implant delivery tube330. If desired, multiple orientation alignment grooves 605 and multiplecorresponding orientation alignment posts 610 may be provided. Bycontrolling the degree of rotation of the proximal implant delivery tube330 one can vary the rotational orientation of proximal implant 210relative to distal implant 205 once proximal implant delivery tube 330is advanced distally so as to engage proximal implant 210 and tab 610 ismated with groove 605. FIG. 106 shows how, in one form of the presentinvention, a rotor knob 615 may be provided which can be used to controlthe orientation of proximal implant 210 relative to distal implant 205.Rotor knob 615 exerts a rotary force on proximal implant tube 330 suchthat when rotor knob 615 is rotated, rotor knob 615 rotates implant tube330. By way of example but not limitation, in one form of the presentinvention, when rotor knob 615 is rotated fully clockwise, legs 235 ofdistal implant 205 and legs 295 of proximal implant 210 fully overlapand are aligned. Each half-turn increment of rotor knob 615 can beconfigured to result in a 9-degree orientation difference between legs235 and legs 295. Rotor knob 615 may have discrete set points (orstopping points) corresponding to each 9-degree increment of the rotor.Each one of these set points can be configured to correspond to theangles of 9-degrees, 18, 36 degrees (which is the maximal misalignmentbetween the legs), 45, 54, 63, and 72 degrees (corresponding to fulloverlap of the legs) between two legs 235 and legs 295. The deliverydevice may have a display that indicates the angle between legs 235 and295 that is incremented or decremented by 9-degrees depending on thehalf rotation of rotor knob 615 in the clockwise or counter-clockwisedirections. Other discrete angle steps or increments between legs 235and legs 295, or a continuous range of angles are also possible,depending on the particular configuration of the design of rotor knob615.

The design and mechanism of action of two-part fastener 200 ispreferably such that when deployed and locked (e.g., withinwardly-projecting tangs 300 disposed in windows 265, the individuallegs 295 of proximal implant 210 alternate with, and interdigitate with,the individual legs 235 of distal implant 205. FIGS. 109-111 areschematic views of a fully-deployed two-part fastener 200 (including atop view) looking down (i.e., looking distally) onto a deployed two-partfastener 200 and with the proximal and distal walls apposed. FIG. 107 isa photograph of a deployed fastener with offset legs 235 of distalimplant 205 and legs 295 of proximal implant 210. Variable offsetbetween legs 235 and legs 295 allows for the adjustment of clampingtension applied to the tissue. By way of example but not limitation, fordelicate or easily damaged or torn tissue (e.g., brain tissue), ortissue that has limited elasticity, it is generally preferable that legs235 and legs 295 substantially completely oppose one another (i.e.,align with one another) so that no lateral tension is applied to thetissue. Similarly, for lung tissue, it may generally be preferable forlegs 235 and legs 295 to have a substantial degree of overlap, so as tominimize the tension applied to the tissue.

On the other hand, for many vascular applications, maximuminterdigitation (i.e., minimum overlap of the legs 235, 295) isgenerally preferred (e.g., an angle of 36 degrees between legs 235 andlegs 295 may be desired) so as to maximize the tension applied to thetissue whereby to occlude the vessel.

With interdigitation of the legs 235 and legs 295 tension is projectedacross the tissue, with the closing force extending beyond the physicaldimensions of legs 235 and legs 295 themselves.

Thus it will be seen that the disposition of legs 235 of distal implant205 relative to the disposition of legs 295 of proximal implant 210 maybe controlled so as to apply a desired clamping force according to thetype and/or condition of the tissue which is to be clamped.

FIG. 112 shows a number of photographs that better illustrate howtwo-part fastener 200 effectively clamps tissue (in this case asimulated blood vessel). Legs 235 of distal implant 205 and legs 295 ofproximal implant 210 are shown interdigitated. This causes ripples, orfolds, in the tissue that act to extend the effective closure, andapplies the closure force to the vessel well beyond the region directlycontacted by the fastener legs 235, 295. By way of example but notlimitation, a two-part fastener 200 having a physical occlusion diameterof 5.5 mm is able to close vessels that are over 7 mm (and even equal orgreater to 1 cm) in diameter.

In one embodiment of the present invention, and looking now at FIG. 113,legs 295 of proximal implant 210 and legs 235 of distal implant 205 maybe beveled (or rounded) so that legs 295, 235 are not sharp, and legs295, 235 may be designed to point away from the tissue to be clamped atthe free end of each leg (i.e., on the end of the leg away from thedistal implant locking tube 220). This is in order to minimize anycatching or damage that may be imparted on the tissue by legs 235, 295,whereby to minimize tearing or ripping of the tissue. In otherembodiments of the present invention, it may be desirable to providesharp ends to legs 235, 295 so that legs 235, 295 catch or pierce thetissue for better gripping. Legs 235, 295 may be smooth, or the surfaceof legs 235, 295 may be roughened, e.g., through chemical etching ormechanical means, so as to enhance the reflectivity of the implants, orto provide maximum tissue capture and gripping.

Looking at FIGS. 112 and 113, it can be seen that (i) legs 295 ofproximal implant 210 and legs 235 of distal implant 205 alternate andinterdigitate with one another, and (ii) the distal ends of legs 295 ofproximal implant 210 pass distally of the proximal ends of legs 235 ofdistal implant 205, and vice versa. In effect, when fully deployed on anartery or vein, or duct, or other organ tissue, there is a predominantlycircular occlusion of the vessel around distal implant locking tube 220by legs 235, 295 of the distal implant 205 and proximal implant 210,respectively. This circular occlusion resembles, in some ways, a “piecrust” pattern in which the proximal wall and distal wall of the vesselare brought into apposition with one another, with distal implantlocking tube 220 at the center of the “pie”.

FIG. 113 shows the shear stress induced between the interdigitation oflegs 235 and legs 295, acting to pull the tubular structure apertureclosed.

FIG. 114 shows how a plurality of forces may be applied across thevessel using the interdigitation of legs 235, 295 of two-part fastener200 of the present invention.

FIG. 115 shows, with the cross-sections a-b and b-c, the strains inducedin a vessel by the clamping forces generated by the interdigitated legs235, 295 of two-part fastener 200.

FIG. 116 is a top view showing tissue folding when legs 235 and legs 295of two-part fastener 200 are interdigitated with one another. The dashedlines show the regions where the tissues are pulled together so as totouch. When legs 235, 295 are interdigitated, a force is applied thatradiates beyond the physical length of legs 235, 295 extending theclamped tissue closure beyond the diameter of the physical legs.

Due to the interdigitated mode of operation, the estimated sum of theproximal and distal wall thicknesses of the vessel that is to beoccluded does not necessarily determine whether an effective occlusioncan be achieved. Since the occlusion components (i.e., legs 235 and legs295) cross each other's plane when deployed, the proximal and distalwalls of the vessel are brought into opposition with one anotherregardless of their summed wall thickness, i.e., 2.0 mm veins haveapproximately 0.2 mm wall thickness (0.4 mm combined), as compared to a3.5 mm muscular artery having approximately 0.6 mm wall thickness (1.2mm total combined) and even a 7.0 mm muscular artery havingapproximately a 1.0 mm wall thickness (2.0 mm combined). Each of thesevessels, with varying dimensions, can be effectively occluded usingtwo-part fastener 200 due to the way two-part fastener 200 ligates thevessel. The interdigitation of legs 295 of proximal implant 210 and legs235 of distal implant 205 means effective closure can be realized evenwith very thin tissue, since legs 295, 235 of the fastener componentscross each other's plane when two-part fastener 200 is deployed acrossthe tissue.

In one embodiment of the present invention, where legs 295 of proximalimplant 210 and legs 235 of distal implant 205 are interdigitated, theforce needed to close the vessel disposed between proximal implant 210and distal implant 205 using two-part fastener 200 is much less than theforce needed to close the same vessel with a conventional ligation clip.This is due to the fact that, in the case of two-part fastener 200,interdigitated legs 295, 235 are pushing against tissue, causing thetissue waviness, bending, or folding, but are not pushing up against thefull force of counter-set legs 295, 235. This means that vessel closurecan be realized with a reduced level of force or pressure on the tissue.

FIG. 117 is a histological section showing the residual impact on thevessel cross-section occluded by legs 295, 235 after vessel healing ofup to 30 days. The vessel is completely occluded and the vessel walltissue is compressed together and, with early healing, “healed”together. The effect of the sheer forces collapsing the vessel wallstogether can be seen in FIG. 117. The “pie crust” closure may beobserved more clearly as well. The arrow indicates the collapsedundulating artery. AVO indicates the location of the interdigitatinglegs of two-part fastener 200.

The two-part fastener 200 of the present invention may be used toocclude vessels, ducts and/or to compress tissue so it isoccluded/compressed at forces less than 700 grams, while the forcerequired to seal off vessels or clamp tissue with a Ligaclip are about10 times greater. The delivery system for two-part fastener 200 impartsa force which is transferred directly from the operator to two-partfastener 200. This reduces requirements and levering on the deliverydevice and the amount of force or pressure an operator may need toapply. The two-part fastener 200 of the present invention, can maintainoperation in the elastic regime and does not need to be plasticallydeformed to realize occlusion.

6. Novel Clip with Interdigitated Fingers

It should be appreciated that the use of interdigitated legs to occludea vessel may extend beyond use with two-part fastener 200. By way ofexample but not limitation, a novel clip 625 comprising interdigitatedand at least in part horizontally spaced legs 630 connected at a commonend 635 may be provided.

FIGS. 118-120 show a novel ligating clip 625 which uses interdigitationof legs 630 (deployed alternatingly on the proximal and distal sides ofthe vessel) to create vessel closure. Once again, sheer stress isinduced so as to close the vessel or duct. The interdigitation of legs630 will also reduce the likelihood that the tissue being clamped willslip out, or that the clamp will fall off. In this case, similar to ahemo-clip, legs 630 of ligating clip 625 are “squashed” together acrossthe vessel to be occluded or tissue to be attached. In one embodiment ofthe invention, legs 630 are pushed so that the tips of legs 630,deployed on the distal side of the vessel, are now above the tips oflegs 630 deployed on the proximal side of the vessel, crossing eachothers plane, so that the tissue between them is stretched closed.

7. Delivery of Multiple Two-Part Fasteners

The ability to deploy multiple two-part fasteners 200 during a procedurecan be an important advantage in numerous applications. By way ofexample but not limitation, when treating venous reflux disease,multiple reflux sites may need to be occluded, or a certain length ofvessel may need to be occluded, and it may be desirable to utilizemultiple two-part fasteners 200 to achieve this. By way of furtherexample but not limitation, when preparing a vein or artery to be usedfor a bypass procedure, multiple branch or tributary vessels need to beoccluded, and multiple two-part fasteners 200 of the present inventionmay be used. By way of example but not limitation, when it is desired toisolate the region between two parts of a vessel or duct by cutting theregion between the two parts (e.g., when removing a bile duct), onetwo-part fastener 200 may be deployed on either side of the region to becut, so as to prevent blood loss. For example when desiring to remove agall bladder the cystic duct needs to be ligated to prevent spillage ofbile from the common bile duct or harvesting an organ, such as thekidney, for transplant or removing part or the entire organ, such as thespleen, for therapeutic considerations.

There are several ways in which multiple two-part fastener's 200 can bedelivered.

8. Reusable Handle with Disposable Tip

Looking next at FIGS. 121 and 122 multiple two-part fasteners 200 may bedelivered using a plurality of single use disposable delivery devices640, wherein each single use delivery device 640 contains a singletwo-part fastener 200. With this form of the present invention, eachsingle use disposable delivery device 640 is used to deploy a singletwo-part fastener 200, and then the single use disposable deliverydevice 640 is disposed of after use. Multiple single use disposabledelivery devices 640, each incorporating a two-part fastener 200, may bepackaged as a single sterile package (e.g., 3 or 6 single use deliverydevices to a sterile package). After a sterile package is opened andsome (or all) of the single use delivery devices are used, all singleuse delivery devices must be discarded. Alternatively, each single usedisposable delivery device 640 may be packaged in its own sterilepackage.

Looking now at FIG. 122, in one form of the present invention, there isprovided a disposable delivery device for delivering a single two-partfastener 200. FIGS. 123 and 124 show the deployment steps for anembodiment of the delivery device. FIG. 124 shows: (a) hollow needle 305passing through the blood vessel, (b) deployment of distal implant 205,(c) retraction of hollow needle 305 and deployment of proximal implant210, (d) using push rod 320 to lock proximal implant 210 and distalimplant 205 together. The next steps (not shown), involve retraction ofproximal implant delivery tube 330. Exposing the junction between distalimplant locking tube 220 and distal implant delivery tube 310, androtating a knob 620 (FIG. 122) which rotates distal implant deliverytube 310 and releases it from distal implant locking tube 220, releasingtwo-part fastener 200 from the delivery device. The delivery device isthen removed leaving two part fastener 200 deployed.

In another embodiment of the present invention, and looking now at FIG.125, hollow needle 305 of the delivery device may contain two-partfastener 200, and once deployed, hollow needle 305 may be removed fromthe handle of the delivery device, and a new hollow needle 305(containing a two-part fastener 200 disposed therein) may be affixed tothe delivery device and used to deploy a second two-part fastener 200during a given procedure. As such, the handle and delivery element areretained throughout the procedure, while the hollow needle 305 (andhence the two-part fastener 200 contained therein) is replaced. Thisform of the invention enables the delivery device to be reused multipletimes during a procedure, while the individual two-part fasteners 200are deployed and the plurality of hollow needles 305 are discarded.Hollow needle 305 can be attached to the handle (which is pre-loadedwith a two-part fastener 200) prior to delivery of a two-part fastener200, and detached following delivery of the two-part fastener 200, andreplaced with a new hollow needle 305 (which is pre-loaded with anothertwo-part fastener 200). This approach enables the delivery of multipletwo-part fasteners 200 during a single procedure, and reduces the costof the system, since the handle and delivery element is generally morecostly than a hollow needle 305 which is pre-loaded with two-partfastener 200.

In one form of the present invention, the handle and delivery elementcan be sterilized and reused for multiple procedures.

In one form of the present invention, hollow needle 305 is configured tobe threaded and screwed into the delivery device. See FIG. 125, which isa cross-section of two-part fastener 200 pre-loaded in a hollow needle305 which is attached to the delivery device using a releasable lockingmechanism 645.

FIG. 126 shows a cross-section of hollow needle 305 with two-partfastener 200 pre-loaded inside, and a releasable locking mechanism 645for attaching hollow needle 305 to the delivery device. FIG. 127 is anexternal view of hollow needle 305 showing releasable locking mechanism645. See also FIG. 128, which shows the reusable delivery device.

9. Rotating Barrel

In still another form of the present invention, multiple two-partfasteners 200 can be disposed within a single delivery device. In onepreferred form of the present invention, and looking now at FIGS.129-139, multiple two-part fasteners 200, each contained within theirown hollow needle 305, may be loaded into chambers 650 in a barrel-likecartridge 652, which in turn is mounted to a housing 665, whereby to bedeployed one after another as will hereinafter be discussed. In otherwords, in this form of the present invention, rather than having ahollow needle 305 that is pre-loaded with a two-part fastener 200 andattached to the same delivery device, the multiple two-part fasteners200 are each loaded into their own hollow needle 305 and into chambers650 of cartridge 652, whereby to allow the delivery of multiplefasteners deployed one at a time, each through its own correspondinghollow needle 305.

In one preferred form of the present invention, cartridge 652 rotates,and plungers are used to first deploy the pre-loaded hollow needle 305contained within cartridge 652 across the tubular structure (or tissue)to be occluded (or clamped), and then used to deliver the pre-loadedtwo-part fasteners 200 contained within the hollow needle 305.

FIGS. 129-139 show the device and delivery mechanism for deployingmultiple fasteners in greater detail. FIG. 129 shows six hollow needles305, each contained within their own chamber 650 within cartridge 652.Cartridge 652 is controllably rotatable via rotation of a knob 653.Rotating knob 653 rotates rotator element 654 which serves to rotatebarrel 652 to the next stop notch 655, which stop notch 655 correspondsto the next chamber 650 of barrel 652. A needle push rod 660 is actuatedby a lever 656, proximal implant delivery rod 680 is actuated by lever657, and proximal implant delivery tube 690 (or 330) is actuated by alever 658. When actuated, the levers move corresponding support posts659, 661 and 662 forward towards barrel 652. Note, needle push rod 660,has a reversible latching mechanism 663 provided on the distal end ofneedle push rod 660 which is similar to releasable locking mechanism 645of single use delivery device 640 in that reversible latching mechanism663 allows needle push rod 660 to reversibly latch onto hollow needle305 so that needle push rod 660 can push or pull hollow needle 305.

In use, in order to deliver two-part fastener 200 across a tubularstructure, and looking now at FIGS. 130-133, lever 656 is activated andpulled proximally to move needle push rod 660 distally into chamber 650so that needle push rod 660 latches onto hollow needle 305 and pusheshollow needle 305 at least partially out of cartridge 652. Hollow needle305 (and the delivery device), are then positioned so as to transect thetubular structure to be occluded. Next lever 657 is pulled proximally,whereby to push proximal implant delivery rod 680 distally so thatproximal implant delivery rod 680 locks onto a hook formed on theproximal end of distal implant locking tube 220. Next, lever 658 ispulled proximally so as to deliver proximal implant delivery tube 690 sothat it covers the clasping or locking region between distal implantlocking tube 220 and proximal implant delivery rod 680. Next lever 657is pulled back further proximally, whereby to deploy distal implant 205.See FIG. 135. Then levers 658 and 657 are pulled back furtherproximally, deploying proximal implant 210 and locking distal implant205 and proximal implant 210 together via distal implant locking tube220. Next, and looking now at FIG. 137, levers 657 and 658 are pushedforward distally so as to retract proximal implant delivery tube 690proximally, and to release implant 220 from the delivery device andhollow needle 305. Lever 656 is then pushed forward distally so as toretract deployed hollow needle 305 into barrel 652. See FIG. 138. Barrel652 is then rotated to the next chamber 650 location containing a newhollow needle 305 pre-loaded with a two-part fastener 200. Cartridge 652is rotated by rotating knob 653 of the delivery device. The deliverydevice is now ready for delivering another two-part fastener 200 in thesame manner as discussed above. Note that after two-part fastener 200has been deployed, the empty hollow needle 305 is retracted proximallyand contained in cartridge 652, as shown in FIG. 139.

FIGS. 140 and 141 are top views of a delivery device wherein cartridge652 (sometimes also referred to herein as a “barrel”) contains multipletwo-part fasteners 200, wherein each two-part fastener 200 comprises apair of clamping elements (e.g., distal implant 205 and proximal implant210) and an associated hollow needle 305. In this form of the presentinvention, all two-part fasteners 200 disposed in cartridge 652 aredelivered one at a time through separate hollow needles 305. In thisform of the present invention, while multiple hollow needles 305 areused, only a single delivery mechanism is required. The advantage ofusing multiple hollow needles 305, wherein each two-part fastener 200 isdeployed via a separate hollow needle 305, is that each hollow needle305 is sharp and is not dulled by multiple penetrations through tubularstructures, organs or tissues. With the embodiment shown in FIGS.140-143, hollow needle 305, proximal implant delivery tube 690 andproximal implant delivery rod 680 are pre-loaded into chamber 650. Eachtwo-part fastener 200 is deployed in a manner similar to that discussedabove (i.e., FIGS. 129-139), however, proximal implant delivery rod 680does not require a hook in this case. Therefore, the delivery mechanismof the delivery device may be simplified over the delivery device shownin FIGS. 129-139.

As seen in FIGS. 144-148, in another preferred form of the presentinvention, multiple two-part fasteners 200 are contained within acartridge 652 and are delivered through the same hollow needle 305.Since there is only a single hollow needle 305, the two-part fasteners200 contained in cartridge 652 are loaded one-by-one from cartridge 652into a single hollow needle 305 disposed in the center of the deliverydevice for deployment.

FIG. 148 shows a top view of the multi-fastener single needle deviceshown in FIGS. 144-147, wherein hollow needle 305 is located in thecenter of cartridge 652. In this form of the invention, each two-partfastener 200 is contained in a tube 664. A plurality of tubes 664, eachcontaining a two-part fastener 200, are loaded into the cartridge 652,and into the pre-deployment clamp region 666, where a spring pushes themtowards and into hollow needle 305. Once each two-part fastener 200 hasbeen deployed, a lever or button is pressed allowing the empty container667 to be pushed into the post deployment waste receptacle 668. The pushrods to deploy two-part fastener 200 are located perpendicular to theshown clamp deployment region and can be operated in the same mannershown for the multi-needle deployment device discussed above.

FIGS. 149-171 show another operating concept of a multi-fastenerdelivery device formed in accordance with the present invention, whereintwo-part fastener 200 is delivered through the same hollow needle 305. Abarrel 670, having multiple chambers 675 which can be loaded withmultiple two-part fasteners 200, is plugged into a delivery device, sothat multiple two-part fasteners 200 can be delivered one after theother through a single hollow needle 305, without having to withdrawhollow needle 305 from patient body or from a laparoscopic port.

FIG. 150 shows multi-fastener barrel 670 loaded with two-part fasteners200. The number of two-part fasteners 200, and which chambers 675 areloaded with two-part fasteners 200, may be selected and controlled bythe user.

FIG. 151 shows one embodiment with two-part fasteners 200 beingpre-loaded into the replaceable barrel 670 of delivery device.

FIG. 152 shows a side view of multiple fastener delivery device 665.

FIGS. 153-156 show a proximal implant delivery rod 680 and hook 685locked onto the distal implant locking tube 220 hook of two-partfastener 200. Proximal implant delivery tube 690 covers the latchingregion of the two hooks, thereby securing the connection.

FIGS. 157-161 show how proximal implant delivery rod 680 and proximalimplant delivery tube 690 are pushed in a coordinated fashion (e.g.,together) downward (i.e., distally) so as to push two-part fastener into(and through) hollow needle 305.

FIGS. 162-166 and FIGS. 167-171 show how hollow needle 305 transfixes atubular structure (or blood vessel or tissue) and two-part fastener 200being deployed across a vessel or duct, in a similar manner and withsimilar steps to those shown in FIGS. 63-77. Once distal implant 205 isdeployed, hollow needle 305 is retracted, deploying proximal implant210. Proximal implant delivery tube 690 is then pushed down (i.e.,distally), so as to push and lock proximal implant 210 onto distalimplant locking tube 220, which is disposed between proximal implant 210and distal implant 205, thereby compressing and securing the tubularstructure between proximal implant 210 and distal implant 205. Proximalimplant delivery tube 690 is then raised (i.e., moved proximally),exposing the clamping region between proximal implant delivery rod 680and distal implant locking tube 220. Proximal implant delivery rod 680is then rotated, unlocking it from the distal implant locking tube 220.The delivery device, together with hollow needle 305 is extracted,leaving the implanted transfixed two-part fastener 200 disposed acrossthe tubular structure, blood vessel or clamped tissues.

10. Serial Deployment of Two-Part Fastener 200

In another form of the present invention, multiple two-part fasteners200 may be disposed in the same hollow needle 305, and deployed oneafter another in a serial fashion. See FIG. 172.

11. Occlusion Using Asymmetric Legs 235, 295

FIG. 173 shows the two-part fastener 200 of the present inventionpreventing hemorrhaging caused by the transfixing rod (i.e., distalimplant locking tube 220). There are many applications for which such adevice could prove useful, e.g., in aortic aneurysm repair, particularlyin the thoracic aorta, where, after removal of the aneurysm, the edge ofthe vessel is fragile and attaching a necessary synthetic graft to closethe gap in the vessel by suture is complicated by bleeding from theneedle entry points. This may result in clinical failure, endangeringthe patient or resulting in a complications. Another example is theresection and suturing of the atrial appendage of the heart which may beresected in patients who have an anthemia with clot embolising from thisappendage. Suturing the atrial appendage wall even with the buttresssynthetic material often results in significant bleeding from the entrypoints of hollow needle 305.

FIG. 173 also shows two-part fastener 200 and the surrounding effectivepressure zone. Note that the different overlaps between legs 295 ofproximal implant 210 and legs 235 of distal implant 205 are controllablyadjustable to provide the desired pressure zone and occlusion level.

In one form of the present invention, the pressure zone generated bytwo-part fastener 200 is a circular area extending around the entrypoint of the transfixing distal locking tube 220 (FIG. 174), but inother embodiments the pressure zone may be non-circular, meaning thatthe lengths of legs 235 of distal implant 205 and legs 295 of proximalimplant 210 are not equal along one axis relative to another, so as topermit two-part fastener 200 to be positioned proximal to a branchedvessel or tissue, as shown in FIG. 175.

More particularly, FIG. 175 shows a two-part fastener 200 where the legs235 of distal implant 205 and the legs 295 of proximal implant 210 arenot symmetric, but rather are oval (i.e., shorter) in one dimension thanthe other, allowing placement proximite to interconnection regions. Inone form of the present invention, the orientation of the two-partfastener 200 can be determined using markings disposed on the deliverydevice handle (e.g., an arrow which indicates the long direction of legs235, 295). In laparoscopic or open procedures, the orientation oftwo-part fastener 200 can also be visually confirmed. In percutaneousapplications, ultrasound, or CT imaging can be used to further determineorientation of two-part fastener 200 relative to vessels, ducts, organs,tissue that is are to be clamped or occluded.

12. Tissue Protection

It should be appreciated that it is often desirable to stabilize (e.g.,via clamping) the vessel (or other tubular structure) that is to beoccluded using two-part fastener 200. In addition, it is often desirableto provide a “needle shield” under the vessel (or other tubularstructure) which is to be occluded so that hollow needle 305 does notdamage underlying tissue as it pierces the vessel (or other tubularstructure) which is to be occluded.

FIG. 176 shows a delivery device comprising a gripper (or dissector) 695that holds the vessel (or tissue) in place while it is transfixed, whilealso protecting the underlying tissue, (i.e., tissue which is not to betransfixed), via a needle stop, from being injured by hollow needle 305as it pierces the vessel. The needle stop can also have a sharpknife-like edge, to help first dissect out the tissues to be occludedfrom the tissues to be protected.

13. Lift to Protect

FIGS. 177-179 show examples of prior art dissectors for use in open andlaparoscopic surgery.

Looking next at FIGS. 180 and 189, under certain conditions (e.g., whenhollow needle 305 is being used to transfix a vessel that is inproximity to tissue, organs, or other vessels) it is desirable to deploya device 700 that can be positioned between the tip of hollow needle 305and the vessel to protect, for example, the tissues, organs, nerves, orother biological materials and vessels that may otherwise come incontact undesirably with the tip of hollow needle 305. Otherapplications for which the present invention is used, may require aneedle (or other sharp element) to penetrate tissues, or an organ, andthe envisioned devices of the invention may act as a “shield” (or stop)to protect any tissue or biological material not desired to bepenetrated beyond the desired penetration site or depth.

FIGS. 180 and 181 show dissection of a tubular structure which has been“lifted” so as to be free from surrounding tissue prior to penetrationof the tubular structure by hollow needle 305 and delivery of two-partfastener 200. FIG. 181 shows counter traction by elevation of “dissectorlimbs” 705, 710 which allows easy penetration of the tubular structureby hollow needle 305 but does not control depth of penetration by hollowneedle 305, thereby allowing underlying tissues to be penetrated and/orinjured by hollow needle 305.

FIG. 182 shows another form of dissector formed in accordance with thepresent invention which may be used for dissection of the tubularstructure so as to free the tubular structure from the surroundingtissues. Dissector 715 provides for elevating and counter-traction aswell as providing a shield 720 to limit the penetration of hollow needle305 into the surrounding (i.e., underlying) tissues, structure orviscera. More particularly, FIG. 182 shows dissector 715 in the closedneutral position. The dissector preferably comprises two limbs 705, 710having curved distal tips 725. One distal tip 725 of dissector 715comprises two superimposed curved blades 730, 735 connected to acontrolling rod 740. FIG. 183 shows how depressing controlling rod 740moves the two curved blades 730, 735 of dissector 715 apart. Rotation ofcontrolling rod 740 rotates the moveable portion of the dissector tip(i.e., curved blades 730, 735). If desired, the second limb 710 ofdissector 715 has of a single, fixed curved blade 730. In anotherembodiment of the invention, the dissector tips 725 can be flat, and canbe controllably rotated outward protruding away from the blades.

FIG. 184 shows the closed neutral position of the adjustable limbs 705,710 wherein the two curved blades 730, 735 lie in apposition (i.e.,lying on top of each other). The movable curved blade 735 is connectedto controlling rod 740 which can be depressed and rotated. In thisembodiment, dissector 715 is designed such that limbs 705, 710 canoverlap, so that they can be easily delivered through, for example, astandard cannula for laparoscopic procedures. FIG. 185 shows that, byrotation of limbs 705, 710 of the dissector the dissector can be broughtinto an operational configuration.

FIG. 186 shows another form of dissector 745 formed in accordance withthe present invention now opened and comprising two “limbs” a first limb750 having a single tip 755, and a second limb 760 having a doubleadjustable tip 765. A rod 770 is mounted to the movable component of thedouble dissector tip element 765. FIG. 187 shows the vessel (or tubularstructure) to be penetrated by hollow needle 305 and the surrounding orunderlying tissues.

FIG. 188 shows the vessel (or tubular structure) has been dissected fromthe surrounding tissues and elevated by the two distal tips (or blades)755, 765 and the hollow needle 305, is being readied to penetrate thevessel (or tubular structure).

FIG. 189 shows rod 770 being depressed and separating the two elements775, 780 of double adjustable tip 765.

FIG. 190 shows the extended distal blade (shield) 780 of the dissectortip being rotated by rotating rod 770 so that the extended distal bladepoints toward the second dissector tip 755.

FIG. 191 shows shield 780 in place as hollow needle 305 penetrates thevessel (or tubular structure). Shield 780 limits the distal penetrationof hollow needle 305 and protects the surrounding tissues, organs andstructures (e.g., nerves, arteries, veins, etc.). While the embodimentof FIG. 191 shows the needle separate from the dissector 745, in anotherembodiment of the present invention, the needle may be connected todissector 745 in a way that, once dissector 745 is deployed and shield780 is positioned, the hollow needle 305 can be positioned to transectthe vessel, tissue, duct or organ for deployment of the two-partfastener 200 that clamps the vessel, tissue, duct, organ.

14. Dissector

In yet another form of the present invention, and looking now at FIGS.192-194, a needle stop (or “shield”) 785 may comprise an integral partof dissector 695 support, and the two-part fastener 200 delivery device,and/or hollow needle 305 of the delivery device, may be attached todissector 695 support. Needle stop 785 may be sharp so that needle stop785 functions as a dissector, separating tissue located above the stopfrom tissue located below the stop. In one embodiment of the presentinvention, supports 790 are provided on dissector 695 for supporting thetissue so that it is elevated above needle stop 785. The gap betweenneedle stop 785 and the supports 790 is preferably 1 cm or more, inanother embodiment of the present invention, the gap between needle stop785 and supports 790 is equal to, or greater than, 0.25 cm; and inanother embodiment, needle stop 785 is movable and/or controllable tothe point of having needle stop 785 and supports 790 in contact.

FIG. 192 shows hollow needle 305 attached to dissector 695. If desired,needle stop 785 can serve as a dissector, and may be configured to “foldup” (or roll up, in a similar way to dissector shown in FIGS. 182 and183) so as to minimize the cross-section of needle stop 785 prior todeployment (e.g., so that needle stop 785 can be delivered via acannula).

FIG. 193 shows a vessel or tissue held in place by supports 790 whichcreate a gap between the vessel and needle stop 785. By virtue of theforegoing construction, in one embodiment of the invention, dissector695 may be used to provide sufficient space for deploying two-partfastener 200.

FIG. 194 shows another embodiment of the present invention, whereinadditional supports 790 are provided, and further wherein supports 790are movable relative to one another, whereby to act as clamps tocompress the tissue together and thereby facilitate penetration of thevessel by hollow needle 305.

In yet another form of the present invention, where the tissue holderelement and the protective stop can be pulled together (or pushed apart)so as to create a gap sufficient for hollow needle 305 to be deliveredpast the vessel, organ or tissue to be penetrated by hollow needle 305,distal implant 205 may be deployed into the gap. The protective stop andtissue holder can be sized so as to easily pass through a laparoscopiccannula.

FIG. 195 shows one embodiment of the present invention wherein theprotective needle stop 785 may be used as a dissector, whereby toseparate a biological element of interest from other biologicalmaterial, and wherein the protective needle stop 785 can serve toprotect the biological material from being penetrated by hollow needle305 when hollow needle 305 is used to deliver two-part fastener 200. Thegap between protective needle stop 785 and the tissue holder ispreferably adjustable, and can be controlled by pushing down or pullingup lever 786, which either (i) moves needle stop 785 distally when lever786 is pushed distally, in either a discrete or continuous manner, so asto increase the gap between the tissue holder element and protectiveneedle stop 785, or (ii) reduces the gap between the tissue holderelement and protective needle stop 785 when lever 786 is pulledproximally.

15. “J”-Shaped Needle Stop Deployed Parallel to Hollow Needle 305

In another form of the present invention, and looking now at FIGS.196-199, hollow needle 305 and a novel needle stop 795 contained in asheath 800 may be configured to run parallel to each other such that,once hollow needle 305 is deployed out of a sheath 805, needle stop 795can bend and align under hollow needle 305, whereby to prevent contactbetween hollow needle 305 and the tissue underneath needle stop 795. Inone embodiment of the present invention, hollow needle 305 and needlestop 795 are used in conjunction with forceps (or a dissector) thatsupports the tissue to be transfixed by hollow needle 305.

FIG. 196 shows how hollow needle 305 and needle stop 795 may be deployedusing a cannula (e.g., a laparoscopic cannula) 810 so as to facilitatedelivery through a laparoscopic port. This approach may be used inconjunction with separate dissectors (not shown) and may also comprise ahousing rather than a cannula.

FIG. 197 shows another embodiment of the present invention, whereinhollow needle 305 and needle stop 795 comprise a deformable material ora shape memory material or a material that has been cut so as to allowneedle stop 795 to curve (e.g., stainless steel that has been lasermachined). Needle stop 795 may comprise a tubular structure, ribbon orsolid rod.

FIG. 198 shows deployment of needle stop 795. Once at the desiredlocation, the needle stop is pushed out of its sheath 800 and delivered,deploying underneath the structure which is to be pierced by hollowneedle 305 (to set two-part fastener 200). The depth, length androtation angle of needle stop 795 is typically pre-set so as to locateneedle stop 795 under and around where the tip of hollow needle 305 willbe located.

FIG. 199 shows how, once transfixion is completed, hollow needle 305 isfirst removed from the vessel (i.e., withdrawn proximally) and thenneedle stop 795 is removed. In another embodiment of the presentinvention, needle sheath 805 and the needle stop sheath 800 are notconnected together.

As discussed above, hollow needle 305 and needle stop 795 are preferablydisposed as two separate parallel elements, with needle stop 795attached to a hollow tube (or entirely made from the hollow tube)preferably comprising a shape memory or superelastic material (e.g.,Nitinol). However, it should also be appreciated that, if desired,needle stop 795 and hollow needle 305 may be arranged, at least in part,co-axially.

16. Push Away Tissue

FIGS. 200 and 201 show a tissue spacing mechanism 815 which may be usedto push tissue located near the distal tip of hollow needle 305 awayfrom hollow needle 305 so as to enable deployment of distal implant 205of two-part fastener 200, with tissue spacing mechanism 815 being usedto form a gap between the target tissue, vessel or organ and theunderlying tissue of a desired distance. This form of the invention maybe used to simplify robotic surgical procedures, since it may eliminatethe need for a separate instrument to dissect, and create the safe spacefor, deployment of two-part fastener 200. See FIGS. 202 and 203.

In another embodiment of the present invention, a ratchet and lockingmechanism may be deployed so as to limit movement of hollow needle 305to only a fixed amount beyond the end of a sheath or the end of alaparoscopic cannula, thereby limiting the depth of deployment of hollowneedle 305 beyond a vessel, tissue or organ to be transfixed.

In another embodiment of the present invention, hollow needle 305 isspring-retractable, so that as soon as hollow needle 305 pierces thevessel, hollow needle 305 immediately retracts, thereby protectingtissue beneath.

17. Two-Part Fastener which Pierces Vessel from Bottom

In the foregoing disclosure, two-part fastener 200 is delivered througha hollow needle 305 that pierces the vessel (or other tubular structurewhich is to be occluded). More particularly, with two-part fastener 200,distal implant 205 is delivered through hollow needle 305 such that whendistal implant 205 is disposed on the distal side of the vessel (orother tubular structure) which is to be occluded, distal implant lockingtube 220 extends through the vessel (or other tubular structure) whichis to be occluded when hollow needle 305 is retracted proximally.However, if desired, hollow needle 305 may by omitted and distal implantlocking tube 220 may be configured to pierce the vessel which is to beoccluded in a distal-to-proximal direction (i.e., so as to pierce thetissue from the distal side of the vessel to the proximal side of thevessel).

Another embodiment of the present invention is shown in FIG. 204. Inthis form of the present invention, a delivery device 825 comprises aholder 830 for distal implant 205, and proximal implant 210 is then sliddown on top of distal implant 205 after distal implant 205 has beendeployed such that distal implant locking tube 220 pierces the vessel(or other tubular structure) which is to be occluded, as willhereinafter be discussed. In this form of the invention, distal implant205 comprises a distal implant locking tube 220 having a sharp end 835which pierces the vessel (or other tubular structure) which is to beoccluded, while proximal implant 210 comprises a cap 840 that caps sharpend 835 and protects adjacent tissue from inadvertent injury due to thesharp end 835 of distal implant locking tube 220. This configuration oftwo-part fastener 200 is especially advantageous for use in opensurgical procedures, but may also be used in laparoscopic and otherprocedures.

More particularly, FIGS. 204 and 205 show distal implant 205 having aspiked distal implant locking tube 220 (i.e., a distal implant lockingtube having a sharp end 835) and mounted onto deployment delivery device825 (e.g., a clamp or forceps).

FIGS. 206 and 207 show delivery device 825 and distal implant 205 beingpositioned beneath the vessel to be occluded, and shows the deliverydevice when delivery device 825 is moved into contact with vessel sothat distal implant locking tube 220 pierces the vessel from the distalside of the vessel in a distal-to-proximal direction and distal implantlocking tube 220 penetrates through the vessel, whereby to exit the far(i.e., proximal) wall of the vessel (or other tubular structure), or thetissue to be clamped, so that the sharp end 835 of distal implantlocking tube 220 is exposed on the proximal side of the vessel.

FIGS. 208 and 209 show a proximal implant 210 mounted to delivery device825 with cap 840 extending through a hole 845 formed in a holder 850,such that proximal implant 210 is releasably retained on the distal sideof holder 850. Note that proximal implant 210 comprises a locking shaft(i.e., tube 275) extending somewhat perpendicular to legs 295 ofproximal implant 210. Tube 275 also comprises cap 840 for lockingproximal implant 210 to distal implant locking shaft 220.

FIGS. 210 and 211 show proximal implant 210 and distal implant 205 beingbrought into contact with one another by aligning distal implant 205 andproximal implant 210. Tube 275 (and cap 840) of proximal implant 210,which is hollow, is locked to distal implant locking tube 220 (which mayor may not be hollow) of distal implant 205. Tube 275 (and cap 840) anddistal implant locking tube 220 may be made of different materials(e.g., titanium and stainless steel) or the tube 275 (and cap 840) anddistal implant locking tube 220 may be made of the same material. Ifdesired, distal implant locking tube 220 and proximal tube 275 may beconfigured such that they are contiguous with legs 235 of distal implant205 and legs 295 of proximal implant 210, respectively.

FIGS. 212 and 213 show how delivery device 825 is removed after distalimplant 205 and proximal implant 210 are locked together.

More particularly, FIG. 214 shows the delivery devices removed, leavingthe vessel occluded using two-part fastener 200. Tube 275 (which may beonly part of proximal implant 210, and made of Nitinol or titanium orother metals) of proximal implant 210 not only serves to lock withdistal implant locking tube 220 of distal implant 205, but also protectssurrounding tissue by covering the sharp end 835 of distal implantlocking tube 220.

18. Exemplary Uses of the Two-Part Fastener

By way of example but not limitation, two-part fastener 200 of thepresent invention may be used for, and in, procedures such as leftarterial appendage occlusion. It should also be appreciated that thetwo-part fastener 200 may be used in cardio-thoracic-vascularapplications such as internal mammary artery bypass surgery where thesecure ligation of branches is critical to the prevention of bleedingand for the treatment for dissecting aneurysms of the aorta (which isgenerally performed by sewing patches onto the native artery so as toallow suture attachment to an interposition graft). With such aprocedure, one problem is typically bleeding through the needle holes ofthe transfixing sutures. The present invention can be used so as topressurize the tissue around the point of transfixion and preventbleeding.

In a similar fashion, when occluding the atrial appendage to preventclot formation and embolization during surgery, the atrial appendagetends to bleed around the needle hole when sutured using a needle. Thenovel two-part fastener 200 of the present invention can mitigate thisbleeding by providing sealing pressure where two-part fastener 200pierces the atrial appendage.

It should be appreciated that two-part fastener 200 may be used as avessel anastomotic device for mechanically joining various vesselstogether.

In addition, two-part fastener 200 may be used so as to allow thereliable fixation of covered stents to the aortic wall in theendovascular treatment of aortic aneuryms, particularly where the stentattachment zone is short and uneven. This may be performedpercutaneously or through a catheter-directed endo-vascular approach.

It should also be appreciated that two-part fastener 200 may be used inapplications involving solid organs where the use of staples may beundesirable or unacceptable.

For example, solid organs do not generally accept conventional staplerssince solid organs bleed through the staple entry points. The two-partfastener 200 of the present invention avoids these issues, and issuitable for parenchymal resection of organs such as the liver, spleen,kidney and lung. The pressurized zone around the transfixing point woundprevents the bleeding that occurs with standard suture technique throughthe needle entry points.

For such applications, it may be desirable to modify the two-partfastener 200 of the present invention so as to form a multi-vesselfastener capable of deploying a row of clips simultaneously, and/or toapply clips laterally to the solid tissue edges.

The two-part fastener 200 of the present invention may also be used forother applications. By way of example but not limitation, the two-partfastener 200 of the present invention may be used in general surgicalapplications, e.g., occlusion of the spermatic cord as an alternative tovascectomy in male sterilization; cystic and bile duct occlusion; bowelfistula or other fistulous tracts, etc. Or the present invention may beused for attachment of tissues, e.g., during hernia repair wheresynthetic materials (e.g., hernia mesh) are used to reinforce the siteof the hernia repair. The two-part fastener 200 of the present inventionmay also be used for secure ligation of the fallopian tube forsterilization procedures. This can be accomplished by the simpleapplication of the two-part fastener 200 of the present invention to thefallopian tube, using open, laparoscopic or robotic surgery.

It should also be appreciated that two-part fastener 200 may be used fororthopedic applications, e.g., as anchors in joint surgery or repair oftendons or ligaments.

And two-part fastener 200 may be used for interventionalradiologically-directed procedures performed under imaging (e.g.,ultrasound, CT, fluorosocopy, etc.), including, but not limited to, theligation of tubular or vascular structures or the coaptation of tissues

When using conventional staples, it is common to also use a buttress,integrating tissue stapling with a buttress provides surgeons with bothgreater functionality and efficiency. The present invention does notrequire the use of a buttress, or support material, as in the case ofthe Endo GIA product, thereby simplifying two-part fastener 200,avoiding the need for additional materials in the body, and reducing thecost and complexity of these procedures. If desired, however, in certaininstances, the present invention could also be used in conjunction withsimilar supporting or buttressing materials.

The present invention can be used in a fashion similar to a stapler foropen surgery procedures (e.g., an open anastomosis).

By way of example but not limitation, two-part fastener 200 may be usedfor the prevention of, or treatment of, blood clot embolization in thepulmonary or peripheral systemic circulation. The present invention maybe used to percutaneously (or laparoscopically or even in open surgery)occlude a vein, in the presence of a vein (superficial or deep) that hasa clot where there is the possibility of propagation and dislodgment ofthe clot into the blood stream in the large veins returning the blood tothe heart and lungs. Two or more two-part fasteners 200 can be placed oneither side of the clot, thereby trapping and containing the clot, orthe occlusion elements may be deployed upstream from the clot, thuspreventing propogation of the clot toward the heart or lungs.

19. Ligation and Injection of Sclerosant or Glues such as ThoseContaining Cyanoacrylate

When a long segment of vein is to be occluded safely, the two-partfastener 200 of the present invention may be used as a clamp at the mostproximal end of the vein, thereby preventing chemical substances (i.e.,a sclerosant or glue containing cyanoacrylate) from directly flowinginto the general circulation of the bloodstream. This allows safer useof either sclerosant or glues, which may be injected in the interveningvenous segment with occlusion in place. See FIG. 215. Large tributariesin an isolated vein segment can also be occluded by placing two-partfastener's 200 at the origin of these tributaries. For injection ofsclerosant or glue to occlude a segment of a vessel, only a singletwo-part fastener 200 (i.e., only a single occlusion site) is necessaryto prevent the sclerosant from spilling over into the more proximalvessel and into the general circulation. See FIG. 216.

In one embodiment of the present invention, there is provided a methodand apparatus for occluding vessels that uses the two-part fastener ofthe present invention and comprises a protruding side needle to deliversclerosant or glue. In this form of the present invention, an fastener(e.g., two-part fastener 200) may be delivered in an upstream region ofa vein, and another fastener (e.g., two-part fastener 200) may bedelivered downstream. The sclerosant or glue is then injected betweenthese fastener elements.

20. Two-Part Fastener Utilizing Electro/RF Cautery

In another form of the present invention, a modified form of two-partfastener 200 may be used to cauterize a vessel, tubular structure,and/or to bond different tissues. More particularly, in this form of thepresent invention, at least a portion of two-part fastener 200 connectsto an electrical cauterizing unit (e.g., monopolar, bipolar, etc.) whichis preferably built into the delivery device.

In one form of the present invention, two-part fastener 200 is connectedto an energy source (or energy sources) and the vessel or duct ortissues may be occluded (or attached, fused, or connected to each other)by the application of RF energy. The RF energy may be applied betweentwo-part fastener 200 and an electrode located in, or on, the patient atanother location (e.g., a patient return electrode), or an electrodelocated between proximal implant 210 and distal implant 205 of two-partfastener 200. The same potential may be applied to both proximal implant210 and distal implant 205 in a monopolar electro-surgery mode, or apotential difference may be applied between the proximal implant 210 anddistal implant 205 in a bipolar electrosurgery mode. The energy sourcemay produce an RF current, where the currents and voltages may bemonitored and controlled and with controllable duty cycles atfrequencies from 200 Khz-3.3 MHz that, so as to optimize the attachmentof the tissues or occlusion of the vessels and ducts, and/or thedenaturing of collagen and other proteins to produce fusion or binding,or coagulation or blending. Once the energy is delivered to the tissues,the occlusion elements (e.g., distal implant 205 and proximal implant210) and the delivery device are removed. See FIG. 226. In one form ofthe invention, distal implant 205 and proximal implant 210 may be heldat the occlusion site for a controllable amount of time afterapplication of the energy and before removal, so as to help ensurebetter occlusion. Distal implant 205 and proximal implant 210approximate the various tissues to a controllable degree, whereby toreduce the amount of energy needed to be imparted to the tissues andvessels, thus reducing damage and maximizing binding. In this form ofthe invention, distal implant 205 comprises a plurality of legs 855, andproximal implant 210 comprises a plurality of legs 860. Legs 855 ofdistal implant 205 and legs 860 of proximal implant 210 providesignificant surface area, or contact area, between an occlusion elementelectrode and the tissue. As such, binding or sealing or connecting oftissue or occlusion of vessel or duct can occur over a large surfacearea. This area can be much larger than the cross-section of thedelivery element probe or device that penetrates the patient skin. SeeFIGS. 223 and 224. In one embodiment of the present invention, theeffective ratio of the diameter of distal implant 205 and proximalimplant 210 to the diameter of the delivery element probe or device maybe greater or equal to 2:1 (and may be up to 10:1 or more). Furthermore,the surface area of tissues that can be connected can be large,depending upon the dimension of legs 860 of proximal implant 210 andlegs 855 of distal implant 205. These legs are the functional equivalentof legs 235 and 295 of the two-part fastener 200.

When distal implant 205 and proximal implant 210 are removed, a hole mayremain which is sealed around the edges in the segment of the occludedvessel duct or tissue. However, if desired, various coagulants orsealants or glues (e.g., cyanoacrylate) may be injected through theneedle or delivery device or a separate different delivery device(injected through a second needle placed near the site) so as to closethe hole in the tissue, and/or to promote healing.

In one embodiment of the present invention, distal implant 205 andproximal implant 210 are extracted through the same hollow needle 305that delivered them.

In one form of the present invention, distal implant 205 and proximalimplant 210 may be decoupled from the electrical energy source once theyhave delivered the electrical energy to the tissue, and then lockedtogether and decoupled from the delivery device so as to remainimplanted, sandwiching the tissue that has been treated with RF energy.This approach may transform (or enhance) the integrity of the tissue(e.g., in bowel or stomach tissue) so as to reduce the likelihood thattwo-part fastener 200 will migrate through the tissue.

FIG. 217 shows a preferred embodiment of the present invention with thedistal implant 205, proximal implant 210 and the insulating element 865being shown before being deployed. FIG. 218 shows an embodiment of thepresent invention where the occlusion elements are deployed. All threeelements are generally contained within a delivery device and a needle(e.g., hollow needle 305) that controls their deployment and delivery oftwo-part fastener 200 through multiple tissue layers or a vessel, ductor fallopian tube.

More particularly, FIG. 217 shows individual electrode elements (i.e.,distal implant 205 and proximal implant 210) and insulating element 865,prior to deployment.

And FIG. 218 shows distal implant 205 and proximal implant 210 and theinsulating element 865 after deployment.

FIG. 219 shows the delivery device with hollow needle 305 attached.

FIG. 220 shows the delivery device with hollow needle 305 penetratingthrough a vessel or tissues.

FIG. 221 shows advancement of distal implant 205.

FIG. 222 shows deployment/opening of distal implant 205 so as to causelegs 855 of distal implant 205 to extend radially outward.

FIG. 223 shows raising of hollow needle 305 and deployment of proximalimplant 210 beyond the tip of hollow needle 305.

FIG. 224 shows legs 860 of proximal implant 210 opening (or in its opencondition) once released from hollow needle 305.

FIG. 225 shows proximal implant 210 and distal implant 205 beingconnected to an electrical energy source 870. In the embodiment shown inFIG. 225, there is a potential difference between the proximal implant210 and distal implant 205. In other embodiments of the presentinvention, the potential difference between both proximal implant 210and distal implant 205 may be the same, and another electrode may beplaced in or on the patient.

FIG. 226 shows the application of energy to tissue, e.g., by theapplication of radio-frequency (RF) current and voltage between theelectrodes (i.e., legs 855 of distal implant 205 and legs 860 ofproximal implant 210) which penetrates through the tissue. The dutycycle and frequency of the RF energy can be adjustably controlled so asto optimize sealing of the tissue or vessel, while minimizing anyburning of the tissue.

FIG. 227 shows that, after application of the RF energy to thesandwiched tissue, distal implant 205 is retracted first. In this case,distal implant 205 is retracted into the insulating element 865.

FIG. 228 shows the fully retracted distal implant 205.

FIG. 229 shows the assembly being raised a little relative to thetissue, with hollow needle 305 being pushed down so that it begins tocompress legs 860 of proximal implant 210.

FIG. 230 shows how hollow needle 305 compresses the legs 860, or fingers(e.g., legs 295) of proximal implant 210, while proximal implant 210 israised relative to hollow needle 305.

FIG. 231 shows how hollow needle 305 (and assembly) are extracted fromthe body, leaving the vessel or tissue sealed.

FIG. 232 shows the sealed tissue region, with the possible needle holesealed around its perimeter.

In another embodiment of the present invention, legs 235 of distalimplant 205 are placed at the tip of hollow needle 305, and then openedand deployed by withdrawal of hollow needle 305, while distal implant205 remains in the same location.

In another embodiment of the present invention, two-part fastener 200 isused in conjunction with a robotic arm for robotic surgery. The abilityto deliver two-part fastener 200 through a needle reduces the number ofsteps and maneuvers that the surgeon must perform, thereby simplifyingocclusion of vessels and/or attachment or approximation of tissues.Also, the amount of surrounding tissue required to be cleared around thevessel is reduced.

21. Novel Handle

The sequence of events required to deliver the occlusion device, asdescribed above, may be automated using a system of motors and springs,and may be powered by a power supply or battery that may or may not berechargeable. It should also be appreciated that, if desired, the devicemay be powered by a solar cell built into the system. In one embodimentof the invention, the entire delivery may be activated through a singlebutton.

FIG. 233 shows an ergonomic design for a novel handle 875 formed inaccordance with the present invention that may contain a battery (notshown) in order to provide the necessary energy to seal tissue orautomate various delivery device actions or alternatively, the presentinvention could be connected to a transformer and/or electrical outlet.In other embodiments, the present invention is simply a mechanicaldevice and not connected to any energy source such as AC or DC voltageand current.

FIGS. 234 and 235 show a refined handle design of a delivery device forfastener implant 200. The refined handle design uses sliders to actuatedeployment of proximal implant 210 and distal implant 205 and lock themtogether.

In practice, a vessel is occluded by sliding handle 875 aside, and thensliding it all the way down, as seen in FIG. 234. This brings proximalimplant 210 and distal implant 205 together, whereby to occlude thevessel.

Removal of the delivery device is accomplished by rotating handle 875counterclockwise, until the delivery device detaches from the clip, asshown in FIG. 235. The delivery device is then withdrawn and retrieved(FIG. 236).

Among other things, (i) handle 875 is designed to provide tactilefeedback upon closing of the clip; (ii) the ratcheted control oftwo-part fastener 200 deployment provides precise and controlleddeployment of two-part fastener 200; and (iii) the design of handle 875provides stability and secure holding of two-part fastener 200, and thesolid feel provides physician comfort.

Modifications of the Illustrative Embodiments

It should be understood that many additional changes in the details,materials (e.g., shape memory polymers that are permanent or thatdissolve over time, or carbon nanotube based), steps and arrangements ofparts, which have been herein described and illustrated in order toexplain the nature of the present invention, may be made by thoseskilled in the art while still remaining within the principles and scopeof the invention.

The invention claimed is:
 1. A fastener for securing at least one layerof tissue to another at least one layer of tissue or non-tissuecomprising: a distal implant comprising a tubular distal body, a firstlocking element on the tubular distal body, and a plurality of legsconfigured to assume (i) a diametrically-reduced delivery configurationin which it can be passed through at least two of said layers and (ii) adiametrically-expanded deployed configuration in which the legs areextended radially of the distal body; and a proximal implant, separatefrom the distal implant, the proximal implant comprising a proximaltubular body having a lumen configured to receive the distal body of thedistal implant, a second locking element on the proximal tubular body,and a plurality of legs configured to assume (i) a diametrically-reduceddelivery configuration and (ii) a diametrically-expanded deployedconfiguration in which the legs are extended radially of the proximalbody; wherein the distal body is telescopically receivable within thelumen of the tubular proximal body to connect the first and secondlocking elements together, thereby locking the distal implant and theproximal implant together to be able to engage and clamp at least two ofsaid layers between the deployed proximal and distal legs, the first andsecond locking elements being configured so that, when locked together,the proximal end of the distal body does not project substantiallybeyond the proximal end of the proximal body; the deployed legs of theimplants being configured so that when the implants are locked together,in the absence of tissue and non-tissue, the deployed legs of theproximal implant are interdigitated with the legs of the distal implant.2. The fastener as defined in claim 1 wherein the lengths of the tubularbodies are not substantially greater than the diameter of theirrespective legs.
 3. The fastener as defined in claim 1 wherein thelength of the distal tubular body is less than the diameter of thedeployed distal legs.
 4. The fastener as defined in claim 1 furthercomprising: the deployed legs of each of the implants extending at anangle that defines a concave configuration, the concave configurationsof each of the implants facing in a distal direction.
 5. The fastener asdefined in claim 1 further comprising: the proximal and distal implants,when their legs are in their reduced diameter configuration, beingcontainable within a delivery needle.
 6. The fastener as defined inclaim 5 further comprising, in combination, the delivery needlecontaining the proximal and distal implants.
 7. The fastener as definedin claim 1 further comprising: the proximal end of the proximal implantbeing detachably engageable with a delivery shaft to enable adjustmentof the rotational orientation of the legs on the proximal implant withrespect to the legs of the distal implant.